GET TO KNOW OUR TEAM.
Tanja Reischl-Stenske
Managing Director
Tanja is a pharmacist and has been working in the healthcare industry in leadership and executive roles for the past 20 years.
She covers the fields of Product Development, Regulatory Affairs, Production, Supply Chain Optimization, Tech Transfers, Quality Management / Qualified Person, Product Compliance and Pharmacovigilance.
Tanja has long term experience in managing complex intercultural projects. She has been extraordinary successful in the area of Supply Chain Optimization / Cost Reduction, Regulatory Compliance and in the localization of production in Russia.
Christian Stenske
Managing Director
Christian has been working in the healthcare industry for the past 19 years in leadership and executive roles.
He covers the fields of Strategy, Marketing, Sales, Supply Chain Management incl. Supplier Selection and Negotiation, Partnering and Partner Networks, Business Development, Finance and Human Resources.
Christian’s expertise is the transformation of companies. Therefore, he strategically aligns them and takes care of a state of the art implementation based on a structured project plan. His main focus: Increasing the value for the company owners with a healthy mixture of short term success in the context of a long term strategy.
Cristina Almeida
Managing Director TF Portugal
Cristina combines a degree in Pharmaceutical Sciences with a post-graduate specialization course in Clinical Analysis and a PhD in the field of Analytical Chemistry.
In addition, she’s been awarded the title of Specialist in the Pharmaceutical Industry, which allows her to assume the role and responsibilities of Technical Director and Qualified Person.
With professional experience ranging from distribution and manufacturing to holding a position as professor for more than 20 years, she’s originally been supporting us in Quality Management and as a skilled auditor, before also taking on the lead of our Porto site as Managing Director of THE FORCE Portugal.
Ahmet Sahin
Managing Director TF Türkiye
In addition to a B.A. in Economics and an MBA, Ahmet has a broad base of experience in global environments, from manufacturing to sourcing to logistics. Throughout his career, he has been to more than 50 countries for business, and managed a variety of teams across the world.
Not least thanks to his special training and official certification for global technology implementation, his background also includes the implementation and maintenance of supply chain systems and modules – as well as first-hand experience in negotiating, tendering, and managing contracts with companies in the technology sector.
At THE FORCE, Ahmet started out as a reliable part of our Procurement team. After being at the forefront of establishing our Antalya site, he’s also taken on the responsibility of Managing Director of THE FORCE Türkiye.
Robert P. Picard
Managing Director TF North America
Robert is an experienced senior consultant with over 30 years of professional experience in leading positions across the pharmaceutical, biotech, and medical device industries.
His specialties range from new start-up support to shakedowns to process tech-transfers and restarts, while his areas of expertise also include solution implementation, cost reduction, and change management – and not least the continuous improvement of businesses. In all of this, Robert’s strength is in delivering on time and below budget.
At THE FORCE, he not only applies his extensive background in, among other things, business transformation, clean rooms, construction management, and procurement, but also uses his experience to take on the role as Managing Director of THE FORCE North America.
Sandra Berzina
Managing Director TF Latvia
Sandra combines her education as a pharmacist with an MBA, resulting in more than 30 years of professional experience in pharma management so far.
Over the course of her career, she’s taken on various leading and management positions in different sectors within the pharmaceutical field. Her background stretches from acting as pharma inspector to positions in marketing, sales and product management in several international companies in medicines, medical devices, and food supplements alike.
Not least due to acting as vice president of the Pharmacist Society of Latvia and 4 years as vice President of EuroPharm Forum, her specialties also include event organization, a professional project implementation on country level, and people management.
Moto Dohi
Managing Director TF Japan
Moto has more than 15 years of experience in the pharmaceutical industry, with his specialties lying in product development, strategic leadership, and corporate transformation. During this time, he has successfully led cross-functional teams to launch innovative pharmaceutical products, including oncology drugs and medical devices.
His unique expertise in bridging European and Japanese markets make him an invaluable resource for German and other European companies seeking to establish or expand their presence in Japan.
At THE FORCE, Moto focuses on bringing his deep understanding of both pharmaceutical technical and business development as well as of intercultural business practices to our clients in Japan, ensuring they effectively achieve their goals.
Dr. Harald Keller
Director Quality
Harald is a Biologist with over 14 years practical experience in life sciences and healthcare industries. Scientific expertise, knowledge of the GMP/GDP legislation, strong analytical thinking skills plus some drops of pragmatism and creativity are his formula to handle quality related topics successfully.
Harald is an experienced auditor and managed several authority inspections. He has successfully set up whole quality systems for healthcare start-ups and supported customers in their inspection preparation process by providing customized SOPs.
Further fields of expertise are supplier qualification, training systems, GDP and technical agreements for instance./p>
Cláudia Barroso
Practice Lead Quality / QP
Cláudia is a pharmacist specialized in the pharmaceutical industry with more than 20 years of professional experience in the healthcare industry. Due to this, her background comprises position from Quality Control to Quality Assurance to Regulatory, including leading roles, as well as fulfilling the function of Qualified Person.
With both her knowledge in the fields of medicines, medical devices, cosmetics, and food supplements and a focus on global GMP compliance alike, she supports our customers with GxP compliant quality systems – providing everything from the set-up and inspection preparation to maintenance.
In addition to taking on the QP and other key functions on demand, her specialties cover quality consulting, project management, and tech/analytical method transfers.
Jasmin Ritz
Practice Lead Quality
Jasmin is a chemist with a master’s degree in Process Analysis & Technology Management. During more than 3 years in quality management in the medical device industry, she has gained experience as an auditor as well as in the supervision of external audits and inspections.
At THE FORCE, she combines her straightforward and pragmatic approach with additional expertise not only in maintaining but also in the continuous improvement of QM systems.
In addition, Jasmin is characterized by a very analytical way of thinking, which she has already successfully applied to various projects, not least in the field of design transfer.
Carlos Mayorga
Practice Lead Quality
Carlos has three years of professional experience as a Validation Engineer in a pharmaceutical production company.
His fields of expertise range from qualification of production equipment and production areas to the validation of HVAC systems, the development of SOPs and validation protocols. At the same time, his focus lies on GMP-compliance for the whole production plant, including everything from facilities to personnel to equipment.
With a combination of reliability, hard work, and a good sense of humor, he’s not only always expanding his skills and horizon, but also readily sharing his knowledge with us at THE FORCE and our customers alike.
Uwe Rosin
Senior Quality Manager
Uwe has a bachelor’s degree in Biochemistry followed by an honours degree in Pharmacology. In addition to more than 30 years of experience in the broader health care industry, he brings extensive knowledge in product development, manufacturing, technology transfer, and quality assurance to our team.
While his passions lie in technology transfer and auditing, Uwe’s excellent experience also stretches to IV solutions, devices, and allopathic as well as homeopathic preparations from inception to execution.
Through his role as quality manager, combined with his distinct knowledge of GMP and guidelines, he lays the foundation for fruitful and efficient cooperation with a wide variety of customers at THE FORCE.
Heike Gloede
Senior Quality Manager
Heike is a pharmacist with more than 15 years of experience in the pharmaceutical industry. Her background spans from working in global CROs to regulatory affairs, including leading positions in both production and quality control as well as fulfilling the function of Responsible Person.
Her expertise has already led to not only several successful inspections in Germany as well as in Switzerland, but also to gaining MIA for primary packaging units.
At THE FORCE, Heike covers the range of GCP, GMP, GDP, and quality management – and takes care of Regulatory Affairs.
Rania Hassanain
Senior Quality Manager
Rania can look back on more than 16 years of experience in the life science industry, with stations, among others, in Quality Assurance, the production of sterile dosage forms, and GMP compliance consulting for pharmaceutical and biopharmaceutical companies.
In addition to her expertise in the establishment of quality systems and deep knowledge of guidelines and regulations, she leads teams based on trust and enthusiasm, while also driving projects forward in a constructive manner.
As a passionate and driven Senior Quality Manager, Rania’s vision is to elevate quality standards and foster a culture of excellence, compliance, and continuous improvement.
Raquel Correia
Senior Quality Manager
Raquel is a pharmacist with 10 years of experience in the pharmaceutical industry. Given her passion about continuous improvement, the fact that she’s driven by challenges, and her strong believe that Quality is at the core of a successful company, it comes as no surprise that her specialty lies within Quality Assurance.
Over the course of her career, she’s not only completed almost 100 audits in GMP and GDP, from sterile manufacturing to distribution centers, but also hosted dozens of inspections by competent authorities in Europe and Eastern Asia alike.
In addition, Raquel is an expert in both the transformation, harmonization, implementation, and monitoring of QMS and in the implementation of the Falsified Medicines Directive and its ongoing management.
Flávio Pinto
Senior Quality Manager
Flávio holds a master’s degree in Pharmaceutical Sciences and a postgraduation degree focused on Business Management.
In 10 years of professional experience, his focus has been on QMS design, implementation, and daily management vital to guarantee an outstanding business and operational performance, while his specialties also include the compliance of medicinal products, medical devices, and cosmetic products.
At THE FORCE, he applies his expertise in quality management, CSV, and GxP areas, as well as his experience from quality management and operational excellence across multinational and multicultural companies within Europe. His experience benefits our customers, by promoting the compliance of their products, leveraging their business and ultimately, the patient safety and well-being.
Dr. Nihad Hadzifejzovic
Senior Quality Manager / QP
Nihad holds a doctorate in pharmaceutical biology. With more than 17 years within the pharmaceutical industry as a department and division manager in international companies, he has gained extensive experience in the handling of phytopharmaceuticals, medicinal products, medicinal teas, and medical devices.
He is not only proficient in the establishment of the QMS, but has also successfully used his sound experience in project management and structuring to optimize and increase the efficiency of processes in this area. As an experienced QP/FvP, he is also well-versed in the preparation and implementation of both internal and external inspections.
From the company's own laboratory to contract laboratories and customer use, he is highly familiar with method development, validation, and transfer, as well as with stability testing and manufacturing validation.
Simone Groh
Senior Quality Manager
Simone holds a degree in chemical engineering with an additional bachelor’s degree in education, and further qualifications as PSM I and CPIM. She can look back on over 30 years of professional experience in the industry.
Ambitious with respect to high quality, familiar with norms and quality standards, and as certified QM supplier auditor, she has worked in cross-functional, multilingual teams and as a freelancer for large and medium-sized pharmaceutical and medical device companies and their suppliers.
At THE FORCE, Simone strengthens the quality team as an expert for all issues relating to quality and project management, and provides support in business development. Her focus is on projects for the introduction, implementation, further development and digitalisation of QMS using agile project management tools.
Julia Zaitseva
Senior Quality Manager
Julia has a master’s degree in Biophysics as well as more than 10 years of experience in the pharmaceutical and medical device fields.
She’s been involved in projects from launching facilities for the production of liquid and solid dosage forms to medical device production. In addition, she’s also developed and implemented QMS from scratch, achieved GMP and ISO certifications alike, and successfully executed tech transfers.
With not only her regulatory knowledge and a strong dedication to quality principles, but also a sense for teamwork, personnel training, and leadership, she’s a competent partner for all quality related issues for both our team and customers at THE FORCE.
Harpreet Walia
Senior Quality Manager
Harpreet has more than 26 years of experience in the pharmaceutical and biotech industry. Over the course of his career, he’s not only been involved in project management and the implementation of various laboratory and industrial automation systems: he’s also become a subject matter expert in system validation, commissioning and qualification alike.
In addition, he brings hands-on experience in configuring, administering and troubleshooting state-of-the-art engineering systems and laboratory equipment – as well as multiple application software platforms.
At THE FORCE, both our team and clients benefit from the combination of his expertise with a result-oriented and customer-focused approach, and – not least – with Harpreet’s outstanding communication skills and being an excellent team player.
Luisa Thumm
Quality Manager
Luisa has a degree in information management in the health sector and can draw on a wide range of practical experience in all her areas of specialization – from quality management to business administration to project and information management.
At THE FORCE, she applies her expertise in quality management and quality assurance as Quality Manager. One of her special fields is staff qualification within the framework of training and on-boarding measures.
Her experience in regulatory affairs and product approval within Europe in particular gives Luisa an international perspective that benefits us and our clients alike.
Juliana Gavrilenko
Quality Manager
Juliana has not only already more than 18 years of practical experience as a pharmacy technician: in addition to her work at the pharmacy, she attended the vocational school for cosmetics and worked as a specialist cosmetician for several years.
Through her function as quality management and occupational health and safety officer, she also brings with her a distinct understanding of quality management systems – and uses her experience in this area at THE FORCE as Quality Manager, as well.
Nicole Heim
Quality Manager
Nicole combines her background as a nurse and Clinical Research Assistant at a medical device manufacturer with 14 years of experience in the pharmaceutical industry at the service provider side.
Her specialties range from setting up and maintaining PV systems, to her knowledge as an EudraVigilance Expert, to PV audits and CAPA monitoring. Both we and our customers alike benefit from her also gladly passing on her broad expertise, especially due to her competence in organizing and conducting trainings.
At THE FORCE, Nicole's focus is on building quality systems.
Verena Bücker
Quality Manager
Verena combines a bachelor’s degree in Nutritional Sciences and a master's degree in Nutritional Economics with more than 5 years of professional experience in quality management in the food, medical device, and pharmaceutical industries.
At THE FORCE, she continues her expertise in this field, covering areas such as SOPs, change control, and inspections. With her passion for good quality management and structured work, she has been involved in various international projects – from the creation, maintenance and improvement of the QMS in 14 European countries to site certification according to GDP in the Netherlands.
In addition, Verena is experienced in conducting both internal and external audits and in supplier qualification.
Hans Leupold
Quality Manager
In addition to a Master’s degree in Biotechnology, Hans’ professional background spans several years of experience in Quality Control, including leading functions in various CMOs and contract laboratories. Thus, he provides expert knowledge that ranges from QC compliance all the way to the fields of analytical and microbiological method validation, verification, and transfer.
With a particular knack for the development and improvement of quality systems as well as a practical approach, his specialty is the set-up of high-quality systems for complex topics in a pragmatic way.
At THE FORCE, Hans also counts tech transfers amongst his key responsibilities.
Beatriz Reis
Quality Manager
Beatriz is a pharmacist who also holds a master’s degree in Pharmaceutical Sciences.
She combines her degree with 7 years of professional experience in the field of Quality Assurance within the pharmaceutical industry, where her focus has been on the management of change control as well as on quality compliance.
As a detail-oriented person with a collaborative spirit and strong problem-solving skills, Beatriz always enjoys a good challenge and is prepared to tackle a variety of quality management related requests and issues for us at THE FORCE and our customers alike.
Brit Gründlich
Quality Manager
Brit is a trained industrial clerk with a master's degree in Molecular Biology and Physiology. Since 2018, she has been working on both a national and international level, with professional experience in Spain in particular, in the pharmaceutical industry.
Her background ranges from supplier management and qualifications, GMP/GDP audits and contract management in the quality sector to the release of cosmetics, food supplements, and biocides.
At THE FORCE, she tackles every new challenge in quality management as well as all topics relating to GMP and GDP, such as QMS and due diligence, with her open, inquisitive, and thorough approach. Not least, her interest in cultures and languages benefits both our international team and customers alike.
Martina Gjorgjevska
Quality Manager
Martina has a master’s degree in pharmacy and a broad variety of experience in the field of quality management: She’s written SOPs, taken care of the integration of documentation, and been responsible for deviation, quality risk, and CAPA management alike.
She’s also well-versed when it comes to supplier qualification and leading regulatory inspections as well as performing internal audits. With a strong analytical side, another one of her specialties lies in statistical analysis on company performance and the performance of trend analyses.
In combination with her expertise in all quality processes in pharmaceutical manufacturing and wholesale distribution, she’s a reliable partner in quality aspects at THE FORCE, as well.
Dr. Andrea Gall
Qualified Person
Andrea is a specialized pharmacist for drug information. She received her doctorate in Drug Regulatory Affairs alongside her job and can now look back on 16 years of experience in the pharmaceutical industry, including regulatory affairs, quality control and quality management, and manufacturing.
Her areas of expertise are medical devices and the registration of biocides. She is particularly well versed in the Medicinal Products and Medical Devices Act and counts pharmaceutical-legal issues among her specialties.
In addition, Andrea is always pleased to pass on her expertise to other pharmacists in the context of further education, to pharmacists in practical training, and to clinical trainees.
Mario Vaccaro
Qualified Person
Mario holds, in addition to a degree in Chemistry and Pharmacological Technology, a license as a pharmacist.
With more than 10 years of professional experience in pharmacies and the pharmaceutical industry, he has specialized in the areas of GMP inspections and supplier qualification as well as internal and external audits. He combines many years of experience in the pharmaceutical gas industry with the knowledge in the field of medical devices he gained as person responsible for regulatory compliance.
At THE FORCE, Mario realizes his innate enthusiasm to always discover new areas and challenges in order to fulfill his desire for professional improvement and development.
Hugo Tavares
Sr. Manager Supply Chain / Logistics / Transport
Hugo is a Certified Business Administrator. In addition to 10 years in the production and distribution of pharmaceuticals and experience in the field of medical technology, his specialties include export, warehouse management, and rollouts for the establishment of new companies abroad, with a particular focus on the selection of storage locations and supply chains.
At THE FORCE, Hugo combines this broad wealth of experience with his ability to accurately analyze even the most difficult situations. As a specialist in supply chain, logistics, and transportation, he approaches these issues not only with his expertise, but also with a healthy mix of diligence, rationality, and diplomatic skills.
Both we and our business partners benefit from his trustful approach and the open atmosphere he creates for everyone involved.
Christiane Pfeffer
Pharmaceutical Technical Allrounder
Christiane combines a degree in pharmacy and a license to practice pharmacy with experience in both pharmacies and the manufacturing sector. In addition, she has been responsible for the implementation of a variety of tech transfer projects for large clients – from lab scale to process validation and the commercialization of products.
With both an open mind for new things and developing herself in additional fields, most recently shown in her successful qualifications as Clinical Monitor and Graduated Plan Officer, she comes into play as a valuable allrounder in various areas of PV and Quality at THE FORCE.
In combination with her enjoyment of learning new languages and getting to know new cultures, she’s ideally equipped to work with our team and customers in an international environment.
Dr. Andrea Schüssele
Director Regulatory Affairs
Andrea is a certified pharmacist with a doctorate in Pharmaceutical Technology – and a passion for regulatory affairs. She enjoys supporting clients with both strategic regulatory advice and hands-on work on dossiers and applications.
Working for small and big companies, Andrea gained sound knowledge in the development and approval process for medicinal products, as well as experience in quality assurance and pharmacovigilance.
At THE FORCE she uses her experience as a consultant to support companies in obtaining the necessary licenses, bringing new products to the market, and keeping them in the market throughout their entire lifecycle.
Dr. Ivana Klincharska
Practice Lead Regulatory Affairs
Ivana holds a PhD in Biology, and has specialized in CMS topics with a special focus on technology transfers. She has more than 8 years of experience in the Pharmaceutical Industry working on different projects, particularly in various scientific topics, regulatory intelligence and regulatory toxicology.
Her 8 years as teaching assistant at university have brought her a scientific and analytical pragmatism in approaching the challenges of the everyday business world.
At THE FORCE, Ivana acts as an accelerator to the dynamic ‘motion’ in the Regulatory Affairs team, to which she contributes with her spirit, energy, and dynamic nature intertwined with an enthusiasm towards ongoing and new projects. Her problem-solving attitude benefits both the team at THE FORCE and our clients.
Sílvia Rodrigues
Practice Lead Regulatory Affairs
Sílvia has a master’s degree in Bioengineering as well as a PhD in Biomedicine. She combines 3 years of professional experience in regulatory affairs and quality management systems under ISO 9001 with her ambition to constantly expand her skills and knowledge to further topics within the pharmaceutical industry.
This background has provided her with both in-depth know-how and hands-on experience when it comes to the regulatory and scientific support to national and multinational companies in scope of Portuguese and European legislation alike, and regulatory medical writing.
At THE FORCE, Sílvia’s focus is not only on taking care of the regulatory strategy for developing projects as part of our Regulatory Affairs team, but also managing MA applications worldwide.
Dr. Sandra Mahr
Sr. Regulatory Affairs Manager
Sandra holds a PhD in Biology and has specialized in medical research with a particular focus on molecular genetics, immunology, and rheumatology.
With 15 years of experience in the pharmaceutical area, she has not only gained in-depth knowledge in drug discovery and regulatory affairs but is also very familiar with the challenges of drug development and approval.
After her time in the Biotech Industry, she became a consultant and now supports pharmaceutical clients in the implementation of their marketing authorisation projects – regarding possible approval strategies and project management as well as hands-on work on dossiers and applications.
Maryna Pokrovska
Sr. Regulatory Affairs Manager
Maryna is a pharmacist by education with a Diploma of the National Pharmaceutical University as well as a postgraduate certification in Economics and Management in Pharmacy.
From more than 15 years in the Pharmaceutical Industry, she brings the hands-on experience of a variety of complex, international projects, combined with the leadership and communication skills necessary to successfully interact with cross-functional teams from all around the globe.
While one of Maryna’s specialties lies in risk analysis and the development of Regulatory Affairs strategies for emerging markets, she’s also – not least due to her previous contributions to acquisition and in-licensing deals alike – a strong asset to our due diligence services.
Dr. Christine Berger
Sr. Regulatory Affairs Manager
With a background of 10 years in CMC and a keen interest in any kind of medical question, Christine is an expert when it comes to assessment of changes, variation preparations, dossier revisions as well as dossier writing, and other life cycle management activities.
A combination of her experience in the life cycle management of globally registered drug products, her focus on a variety of markets ranging from EU to Brazil to Asian countries, and being in touch with local offices all around the world has gained her an excellent cross-cultural competence, which both our international team and customers at THE FORCE benefit from.
Here, her specialty lies in tech transfers, while she also provides regulatory strategy and communicates with Authorities on behalf of clients.
Carlos Martinez
Sr. Regulatory Affairs Manager
Carlos is a trained pharmacists with an MBA focused on innovation and more than a decade of experience in the pharmaceutical industry. His diverse background includes regulatory roles in companies from start-ups to multinational corporations to consultancy services.
In addition to his expertise in the regulatory life cycle of products and due diligence, as well as a specialization in the Latin American market, he has ventured into the cannabis industry in recent years, where he’s played a vital role in certifying manufacturing plants, supporting the design and formulation of products, and shaping policies for the industry and regulatory activities.
Combined with his entrepreneurial mindset, sharp regulatory strategy, and a passion for finding solutions, Carlos not only supports our clients with a broad variety of regulatory activities, but also ensures their continued growth and innovation.
Lénia Pereira
Sr. Regulatory Affairs Manager
Lénia has a master’s degree in Pharmaceutical Sciences and brings over 10 years of experience in regulatory affairs that she gained in international big pharma as well as in consulting companies.
Her professional journey includes a broad spectrum of European and international projects – ranging from new MA applications to lifecycle management.
At THE FORCE, Lénia continues to pursue her passion for both her work and operating in an international environment, and takes care of a wide variety of regulatory activities. Not only our customers but also our entire team benefit from her team-spirit, distinct problem-solving and communication skills, and – not least – her eye for detail.
Dr. Tina Seitz
Sr. Regulatory Affairs Manager
Tina holds a PhD in human biology and has 7 years of experience from a broad range of projects in the field of regulatory affairs.
As Regulatory Affairs Manager and Information Officer, she has been responsible, among other things, for the maintenance of national and international approvals, the preparation of new approvals, and – not least – a close and smooth cooperation with authorities and partners.
With her structured way of working, a high degree of self-organisation, and the willingness to continuously acquire new knowledge and skills, she is a competent point of contact for all regulatory issues at THE FORCE, as well.
Sara Alkwatli
Regulatory Affairs Manager
Sara is a pharmacist with a bachelor’s degree in Pharmacy as well as 3 years of professional experience in health-tech solutions. Her background includes areas from data analysis and client service to quality assessment and process documentation.
At THE FORCE, her primary focus is on Regulatory Affairs, where she joins and enhances our team not only with her skills, but also with her ambition to invest in and to refine them within the framework of new projects, making her a valuable asset for us and our customers alike.
Dr. Manuela Mattera
Regulatory Affairs Manager
Manuela is a biochemist with a PhD in Molecular and Cell Biology and a scientific background in infectious diseases, bacteriology, and virology. She can look back on more than 5 years of experience in clinical research, in particular in the project management of phase I and II clinical drug trials.
At THE FORCE, Manuela continues to pursue this passion for working in an international environment and communicating in foreign languages as part of the Regulatory Affairs team, with an initial focus on renewal procedures.
As a natural scientist, she brings along an analytical approach to classify data, a distinct comprehension of physical processes, and the creative resourcefulness needed to take on a variety of projects.
Iva Gjolli
Regulatory Affairs Manager
Iva is a state-certified pharmacist who also brings professional experience from various areas of quality management. In addition to developing and maintaining quality management systems, her specialties include the creation and review of quality agreements in particular.
With her motivation and an ambition to continuously develop herself, she not only keeps up to date in the field of GDP, GMP, and GVP guidelines, but also likes to extend her expertise to other areas, such as, most recently, food supplements and foods for special dietary purposes.
At THE FORCE, Iva's focus is on Regulatory Affairs, where – not least in combination with her strong communication skills – she assists our customers from project management to the maintenance of marketing authorizations.
Alina Licova
Regulatory Affairs Manager
Alina holds a master's degree in Pharmaceutical Sciences and brings over 7 years of Pharmaceutical Industry experience to her role. Her professional journey includes a wide spectrum of European and international projects, spanning product registration, procedure management, life-cycle activities, maintenance of Marketing Authorizations, and quality control.
Her expertise has not only resulted in numerous successful variation submissions as well as in securing approvals for cannabis-based products across various countries: Combined with her distinct problem-solving skills, it forms the cornerstone of her collaboration with a broad range of clients at THE FORCE.
Isidora Bojkov
Regulatory Affairs Manager
In addition to a master’s degree in Pharmacy, Isidora can rely on her professional experience in the pharmaceutical industry as a formulation development scientist.
Thanks to this, her specialties include formulation and process development, product transfer, and scale-up, while she’s also well-versed when it comes to the preparation of formulation or process related CMC documents as an integral part of regulatory filings. Not least, she’s built up expertise in supporting the change control process.
Passionate about her work, curious, and always eager to acquire new skills, Isidora takes care of a wide variety of regulatory tasks for our customers at THE FORCE – and is ready for a new challenge at any time.
Dr. Kerstin Tang
Regulatory Affairs Manager
Kerstin has a PhD in Biochemistry and more than 10 years of experience in academic life sciences’ research and development. Her professional background in regulatory affairs and quality assurance for medical devices stretches across various stations within this area, from hands-on work on technical documentations and QMS to working in a German competent authority.
As a natural scientist, she brings along an analytical approach to assess RA and QA projects as well as a distinct comprehension of biological and physical processes, which she combines with a penchant for writing and compiling comprehensive documentations, and – not least – supporting customers in successfully coping with regulatory requirements.
At THE FORCE, Kerstin continues to pursue her passion for medical devices and working in an international environment as part of the Regulatory Affairs team.
Julia Berßem
Regulatory Affairs Manager
Julia has a master's degree in chemistry. After entering the pharmaceutical industry at an analytical service provider in the field of quality control, where her focus was on method development and validation, she found her way to Regulatory Affairs, which she continues at THE FORCE.
Her professional experience ranges from the creation of M1 documents, including updates of product and technical information, and M3 documents, to gap analyses of dossiers for submission into new markets, up to lifecycle management.
Another one of her specialties lies in the preparation and submission of variations for marketing authorizations in Germany, Austria, and Switzerland.
Juho Grönblom
Regulatory Affairs Manager
With already a B.Sc. in pharmacy, Juho is currently finishing his studies to obtain a master’s degree in the same field, majoring in industrial pharmacy.
His professional experience in regulatory affairs ranges from post-approval changes to products under divestment or brand exit, and extends to a PAC reliance pilot project in collaboration with national health authorities, WHO, and EMA alike.
At THE FORCE, he brings a calm and organized approach to our team and, being a quick learner and easily adapting to new tasks, takes care of the whole range of regulatory responsibilities.
Dr. Rudite Schillinger
Director Pharmacovigilance
Rudite is a medical doctor and has a master’s degree in Business Administration. She has more than 20 years experience in the pharmaceutical industry.
Rudite covers pharmacovigilance quality systems, performs PV audits, monitors benefit risk balance of the medicines and maintains a pharmacovigilance system master file.
Rudite’s long term experience in the pharmaceutical field brings together a healthy understanding of business needs and legal requirements. She has been successful in passing EU authority inspections, performing PV audits, implementing PV systems and maintaining effective quality system for monitoring medicines.
Dr. Maren Gonzalez Schmitz
Sr. PV Manager / Graduated Plan Officer / QPPV
Maren dived right into the pharmaceutical industry after her studies, starting out as quality assurance and pharmacovigilance manager. Of the about 20 years since, she’s spent more than 10 in PV, covering a wide variety of topics – from implementing, monitoring, and maintaining PV systems, to adverse drug reaction reports and recalls, to the maintenance of data bases.
In addition, she’s got a doctoral degree in human biology in a clinical setting, including hands-on experience with primary cell-culture.
Making use not only of her affinity for communicating in German, English, and Spanish alike, but also of her curious nature that leads to her always being ready to learn more and to broaden her horizon, Maren has worked with partners all over the world to ensure compliance with PV obligations – which she continues to do at THE FORCE.
Dr. Heena P. Sharma
PV Manager / QPPV
Heena is a dentist who did further studies in drug safety and pharmacovigilance. Overall, she can look back on more than 8 years of professional experience in the pharmaceutical industry, among other things as a subject matter expert in PV operations and working in a med-tech setup with a focus on developing various PV tools and databases.
Her combined experiences in pharmacovigilance, drug safety, and product development not only demonstrate the bright potential of merging the fields of medicine and technology: They also give her a broader perspective in her day-to-day work. At THE FORCE, she implements this into SOPs, trainings, and in managing the PV area in general.
Dr. Edidiong Miracle
PV Manager / QPPV
Edidiong is a medical doctor with more than 2 years of professional experience in the medtech and biopharma industry, focusing on the safety management of medicinal products and medical devices.
He has worked at both the manufacturer and service provider level. There, he has managed the creation of infrastructures for safety oversight at the pre-market as well as at the post-market phase of product development, and the implementation of regulatory activities around these processes.
At THE FORCE, Edidiong takes care of all issues relating to pharmacovigilance, including the fulfillment of the function of QPPV.
Dr. Ana Saraiva
Medical Affairs Manager
Ana is a biochemist with a PhD in Chemical and Biological Engineering. During her 9 years in Medical Affairs, she has worked in cross-functional teams for pre-launch as well as launch activities, development and implementation of tactical plans, clinical research, and medical experts’ engagement projects.
With her global mindset, not least due to her wide range of international experiences, she pursues the diversity offered by an international working environment – and keeps on contributing to innovative solutions for us and our customers at THE FORCE.
In all her work, Ana never loses sight of her personal aspiration that the best care should be easily and timely accessible to every patient around the world.
Dr. Heidi Becker
Practice Lead Toxicology
Heidi is a biologist whose academic background includes a degree in toxicology as well as a PhD in the field of cell toxicology.
She’s worked for both the Federal Environment Agency, with a focus on the assessment of indoor pollutants and on nanomaterials, and as a REACH officer in the chemical industry.
With her vast experience in consulting and advisory services – and a special knack for safety data sheets – she also ensures we and our customers at THE FORCE alike are best informed, no matter if it is about a classification issue, the toxicological assessment of ingredients or impurities in drugs and medical devices, or deriving important limit values.
Célia Martins
Senior Toxicologist
Célia has a degree in Eng. Biotechnology. After her graduation, she started her career as a researcher in the field of genetic toxicology, also passing on her experience by training and teaching students.
Upon completing her PhD in Life Sciences with a specialty in human genetics and toxicology, she fulfilled the role of both coordinator and GLP Study Director within a phytopharmaceutical company laboratory performing non-clinical studies, while expanding her know-how in the areas of regulatory and product safety, as well.
At THE FORCE, Célia follows her passion for toxicology and working with a multidisciplinary team in an international environment. In her work, it’s central for her to be able to deliver expertise for a better life, with less exposure risk, to supply risk assessments, and to derive limit values of exposure for ingredients and impurities.
Henry Nwokedi
Toxicologist
Henry combines not only a bachelor’s degree in Pharmaceutical Sciences with a master’s degree in Toxicology, but also has a background of several years of experience in Pharmaceutical Care.
At the FORCE, he continues to pursue his area of passion by joining the team in solving toxicology-related problems, while also following his ambition to constantly expand his knowledge and skills to other topics in the pharmaceutical industry.
Valentin Degenhardt
Director Procurement
Valentin is a customer-centric procurement leader with more than 15 years of extensive experience across several industries. He’s driven by a passion for enabling procurement organizations to live up to their role and potential – namely as a fuel engine for organizational growth and value creation.
At THE FORCE, Valentin supports clients with an integral procurement service, from providing advice to delivering results as well as momentum. Based on a “one team, one target” mindset, he always provides value with a hands-on execution of strategic initiatives.
Since he thrives on creating rather than simply maintaining, his focus is on procurement transformation, operating model development, supplier and category management, and cost optimization projects.
Theo Andre
Procurement & Supply Chain Manager
Driven by a passion for organization management and procurement challenges, Theo brings an academic background in financial control and a master's degree in procurement, logistics, and production management – as well as over 3 years of experience delivering procurement solutions across multiple industries that help organizations achieve their goals.
At THE FORCE, Theo provides quality procurement and supply chain services to our customers. His focus on end-to-end analysis and strong analytic capabilities enables him to accurately assess complex situations, identify areas for improvement, and optimize operations.
In addition, his commitment to continuous learning and growth empowers him to stay updated with industry trends, allowing him to add significant value to his clients.
Matias Carrillo
Procurement & Supply Chain Manager
Always focused on customer satisfaction as if any company were his own, Matias provides added value through his in-depth analysis, strategic planning, and implementation of practical and creative solutions.
An academic background including a master's degree in International Business, Trade, and Law has allowed him to develop his professional skills for more than 8 years in the tech and international transport & logistics sectors.
With successful experience in cost optimization projects and the implementation of technological solutions to solve complex situations alike, Matias continues at THE FORCE to support our clients in meeting the major challenges of procurement and supply chain.
Priyanka Shetye
Procurement & Supply Chain Manager
Priyanka’s academic background ranges from a bachelor’s degree in Chemistry to a master’s degree in Supply Chain & Logistics Management to a diploma in Material Management.
Her professional experience is just as diverse: While her specialties lie in the strategic sourcing of APIs and CMOs, new product development, and supply chain planning and consulting, her collective expertise covers 14 years spread across the pharmaceutical, chemical, and consumer product industry.
Combined with a self-driven and task-oriented approach as well as her strong managing and planning skills, Priyanka deep-dives into any subject and finds ways for value addition – an ability she also uses at THE FORCE to support to support our customers with an integral supply chain service – from advice to implementation and delivering results.
Patrick König
Director Transformation & Strategy
Patrick combines a degree in Business Administration with more than 15 years of extensive experience in the pharmaceutical industry, in particular in the areas of Specialty Pharma and CDMO.
He has proven his leadership qualities over a period of more than 5 years in managerial roles and established them within the framework of 2 years in executive positions.
At THE FORCE, Patrick leads our transformation and strategy team with not only his expertise ranging from sales and marketing to M&A to the reframing of organizations, but also with a strong hands-on mentality, his open-mindedness, and a special dash of creativity that all allow him to always find the best solutions for our clients.
Kristina Brinster
Senior Manager Pharmaceutical Transformation
Working for 15 years in the medical device and pharmaceutical industry, Kristina has extensive experience in the areas of development, manufacturing, quality assurance and quality control as well as regulatory affairs.
She is not only well-versed in audits and inspections, but also in the strategic alignment of companies and the coordination of processes within CDMO structures. She places particular value on intelligent processes that can be run intuitively and, thus, ultimately guarantee the safety of products and patients alike.
At THE FORCE, Kristina’s solution-oriented and interdisciplinary approach enables her to confidently guide companies through all upcoming changes and transformations.
Sanjiv Singh
Senior Manager Transformation
Sanjiv is a business graduate with more than 20 years of professional experience. In addition to leading and facilitating cross-functional science, IT and business teams, he has proven his transformational and management skills in various roles and projects over the last decade.
He not only combines his degree and a background in innovation, life science and investments: Sanjiv also employs a strong hands-on-attitude and his ability to always think outside the box to get things done – and to carve out the best solutions.
At THE FORCE, he applies his expertise to set up and support complex business-driven transformation projects, effectively translating them into increased success and profitability for our clients.
Dr. Markus Lutz
Director Project Management
Markus holds a diploma in Business Administration and a doctorate in Innovation Management. He has about 20 years of professional experience in industry and consulting, more than 5 years thereof in executive positions. With his distinct ability to structure and prioritize, he assists our clients in making the right decisions at the right time.
Markus has long-term experience in project management as well as in lean management. He has been very successful both as manager and consultant for production, logistics, and R&D within various industries, such as – besides the pharmaceutical industry – medical devices, automotive and machinery.
At THE FORCE, Markus covers project, multi-project, and program management as well as strategy development and execution.
Karla Giacomelli Ribas
Project Manager
Karla has a master’s degree in Pharmaceutical Sciences. Her background ranges from drug product development to the research and development area to leadership roles in various projects.
On top of that, she’s proficient in the handling of current good practice (cGxP) guidelines. In addition to more than 6 years of professional experience, Karla brings in her distinct analytical skills to successfully manage projects in the Quality area at THE FORCE.
One of her specialties also lies in supporting customers in analytical method transfers and method validations.
Débora Pinto
Project Manager
Débora combines a master’s degree in Microbiology, an executive master in International Business, and more than 16 years of experience in the biopharmaceutical industry in the development of biotherapeutics.
During this time, she’s been working with a wide range of companies, from big global pharma to small biotech, which also shows in her vast experiences: While one of her specialties lies in the development, optimization, and implementation of new methodologies and the validation of technology platforms, she’s also gained extensive knowledge in the development and management of internal and collaborative R&D projects.
Well-versed in the successful delivery of such projects across multiple therapeutic areas, she takes care of our customers’ projects throughout the whole lifecycle of project management, as well.
Douaa Hussien
Head of Finance & Controlling
Douaa is a business economist with a focus on Finance & Controlling and Business Administration. Motivation, sense of responsibility, reliability and flexibility characterize her strengths.
With her organizational talent, she not only generally supports the team in analyzing, planning and controlling financial tasks in the company, but also takes on her own projects in this area. It is important to Douaa to always have a clear plan that allows her to achieve the goal and to identify deviations early on.
Luz García
Finance & Controlling
Luz has a degree in Economy as well as 2 years of professional experience as a cost analyst and accounting assistant in the healthcare sector.
At THE FORCE, she uses her background in a variety of controlling tasks and her excellent analytical skills to take care of accounting and controlling functions. Besides, her specialties also include design work in various established programs.
With strong communication skills and a special sense of empathy, she’s an excellent contact point for our clients, both when it comes to assisting their needs and during the sales process – while also constituting a great asset to us internally, in particular when it comes to administrative tasks and day-to-day operations.
Susana Gomes
Accounting & Management Assistant
With not only a degree in Economics and a post-graduation in Labor Law and Portuguese Social Security, Susana is now about to finish her master’s degree in Accounting and Finance.
While she has been working, both in public and private entities, in areas such as administrative, accounting support, and financial consultancy, she also brings relevant experience in the general administration of SMEs.
At THE FORCE, she adds her spirit of mutual support as well as her nature of not being able to say no to a good challenge to the accounting team to guarantee that procedures comply with applicable regulations – and uses these abilities to ensure all administrative tasks and projects are carried out efficiently.
Tanja Dreher
Marketing Manager
Tanja holds a master’s degree in International Business & Economics with a focus on marketing and global business ethics and has over 6 years of professional experience in the field of marketing.
Her core competence lies in the area of online marketing – not least because of her curiosity about new technologies and her openness for the use of new systems. With Tanja, distinctive analytical skills meet a creative streak, which is evident in her ideas as well as in their practical implementation.
With her experience in the development, control and analysis of holistic marketing concepts, she is responsible for campaign management and the implementation of marketing activities on all channels at THE FORCE.
Beatriz de Lima
Graphic Designer & Artworks Manager
Beatriz has a master’s degree in Graphic Design and Editorial Projects, and has been working as a graphic designer within the healthcare industry for the last couple of years.
While her core competence lies in packaging and overall offline media, such as cartons, informative flyers, or outdoor advertising, she’s also well-versed in and passionate about other forms of digital art and areas of application, from social media to illustration.
With a focus on improving graphic design communication and the goal to make a positive impact on people’s lives through the pharmaceutical field, she provides both us at THE FORCE and our clients with solutions to a wide variety of artworks and other design needs.
Renata Ferreira
Graphic Designer & Artworks Manager
Renata has a bachelor’s degree in Graphic Design and more than 10 years of experience in creating artworks and marketing campaigns for the pharmaceutical industry. Throughout her career, she’s not only built up a wide-ranging background, from conceptual design to final execution, but has also taken on the lead in cross-functional design projects, collaborating closely with marketing, product, and regulatory.
Two additional specializations in UX Design and a completed training in Branding and Service Design allow her to approach projects from a strategic and user-centered perspective, as well.
As part of our design and art team at THE FORCE, Renata is involved in supporting our corporate branding strategy and developing artworks for our clients – always ensuring consistency across all design materials and making sure both regulatory standards and creative objectives are met.
Nikolai Wiedemann
Head of IT
Nikolai has a university degree in Information Management with over 10 years of experience in IT systems and system landscapes. As our technical mastermind, he takes care of everything related to technology, with his core competence in IT project management: He combines strategic and conceptual elements with the necessary technical know-how for a target-oriented implementation.
Thanks to his penchant for IT security and a passion for everything that consists of zeros and ones, he keeps himself and the IT landscape at THE FORCE constantly up to date, even with the fast-moving developments in the IT sector, and continues to develop both.
Moreover, he ensures that all employees have quick and uncomplicated access to all the resources they need to develop their business areas.
Andre Braga
Senior IT Manager
In addition to successful studies in Computer and Telecommunications, Andre has built up and expanded his IT support skills in stock market as well as hospitality companies throughout his career.
Infrastructure management and security architecture development are equally part of his daily routine as getting up to date with current trends and exploring the world of Tech, as he always seeks to draw on the latest expertise and test new solutions in his work.
At THE FORCE, Andre also takes on IT support, enjoying the opportunity to assist colleagues and customers alike, the sense of accomplishment in solving even the trickiest issues – and the fact that the fast-paced IT environment makes every day a new challenge.
Kadir Sert
Senior IT Manager
Kadir holds a bachelor’s degree in Information Technology with a focus on network security, which is complemented by a master’s degree in Management and Organization.
Over the course of his career and various key roles, he’s significantly contributed to advancing technology in healthcare services: He has successfully lead teams in implementing innovative solutions, enhancing cyber security measures, and optimizing IT operations in alignment with organizational goals.
Driven by his passion to continuously develop the IT landscape, Kadir always brings his expertise, leadership skills, and not least his priority to foster collaborative and positive work environments to the challenge at hand – and thus succeeds in driving impactful change.
Verena Winter
HR Manager
In addition to a bachelor’s degree in business administration, Verena has several years of professional experience from various projects in HR and assistance. Combined with her interest in languages, traveling, and getting to know international cultures, she is well-equipped to deal with the diverse pool of candidates and employees at THE FORCE.
As HR Manager, she is not only responsible for recruiting and onboarding, but also for all topics and projects along the employee lifecycle, in particular personnel development and the integration of international locations into the HR environment.
She acts as a point of contact for employees, managers, and management alike – and is always up to date with the latest trends and developments.
Karin Johnson
Office & Social Media Manager
Karin pairs a Bachelor of Business Administration with a strong background in banking and customer service as well as over 15 years of experience in managing large teams.
In combination with a well-organized, inclusive way of work – and not least with a good dose of determination – she uses her skills to guarantee a smooth and efficient administration of our Berlin office.
Always eager to dive into the latest software developments, learn to use new tools, and try out current trends, the most recent addition to her expertise is a diploma in Digital Marketing and Social Media which she puts into action at THE FORCE in her role as Social Media Manager.
Linda Zoccatelli
Customer Service / Management Support
Linda has not only many years of experience in supporting international customers: In combination with further commercial training, she has been able to expand her know-how to include other activities in the international environment and has worked in both export and international business development throughout her career.
In addition, her strengths lie within the administrative and organizational area, which she also brings to use in her work with clients and employees from a wide variety of background at THE FORCE – with strong communication skills, a talent for conflict resolution and, not least, her openness to new languages and cultures.
Dr. Racha Helal
Executive Assistant
With a Ph.D. in Pharmacy and extensive hands-on experience ranging across pharmaceuticals, digital health, and business management support, Racha thrives in dynamic and complex environments.
Her strong organizational skills as well as her expertise in executive assistance enable her to efficiently manage a wide variety of projects, to drive strategic initiatives, and to support high-level executives in a reliable and effective manner.
At THE FORCE, Racha combines her diverse background and skills, allowing her to not only guarantee a smooth running of essential operations, but also to streamline operations, foster innovation, and significantly contribute to the success of the organization.
Michael Flach
Business Development
Michael has been supporting the establishment and transformation of companies from a wide range of industries for more than 17 years. As a trained industrial clerk, he studied industrial engineering and – alongside the job – nano-biotechnology.
After graduating, he worked as a business development manager for a development company before moving into the investment business. He has been active for both institutional and private investment companies and accompanied more than 15 young and medium-sized technology companies in their development.
Michael covers the areas of strategy, business development, and financing, with a sustainably profitable company development always in the focus of his activities.
Henning Neubauer
Senior Business Development Manager
Henning has more than 20 years of experience in the pharmaceutical industry, which have made him not only a professional in all relevant dosage forms but also allowed him to build a well-established, worldwide network within the industry.
With a special emphasis on business development and business management during this time, his proven track-record includes successfully generating new business as well as realizing various types of relationships and establishing long-term partnerships.
At THE FORCE, he combines his both customer and project driven approach with a clear focus on commercial success to enable our – and not least our customers’ – business to thrive.
Laura Leupolt
Senior Business Development Manager
Laura has spent more than 20 years in the area of OTC, food supplements and RX. Her specialties lie in sales and business development, contract manufacturing across a wide variety of different dosage forms, and the in- and out-licensing of technologies and products alike.
Also well-versed in commercial operations and leading teams, she’s got hands-on experience in setting up an office, including everything from building up a team, developing a customer base, and establishing customer relationships.
Combining this expertise with her prior roles and contacts, she’s best prepared to interact with international teams, partners, and customers in the field of business development at THE FORCE, as well.
Aleksandr Oblezov
Project Manager
Aleksandr is a chemist with 17 years of professional experience in the pharmaceutical industry, including stations in general management and as a plant manager.
His expertise is in product development, tech transfer and manufacturing.
As an experienced project manager in various fields of medical devices and the pharmaceutical industry, he uses his diverse background – ranging from construction projects to drug solid form optimization – to take care of managing manifold projects at THE FORCE, as well.
Patrick Vogel
Director Software Development
Over the course of his career, Patrick has held a variety of positions and tackled a wide range of tasks.
In recent years, he has specialized in competence management and software development within the area of business consultancy, where he has – always ahead of his time – developed innovative software concepts and successfully implemented them in consulting.
While he and his wife also dedicate themselves to the topic of "indulgence at the highest level" and he has completed further training as a fromelier, at THE FORCE Patrick covers the areas of software development, ITC, security, and sales with the same quality standards.
