Job Description Summary
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Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us - the future is ours to shape!
As the Senior QA Manager/Responsible Person (FvP) for development stage medicinal products and materials at Sandoz AG, you will lead strategic and technical quality oversight for the Development Supply Chain in all GDP-related matters. You will ensure full compliance with Swissmedic regulations, including Articles 17 and 21 of the AMBV, and uphold the standards of the Sandoz Corporate Quality Manual.
This role offers a unique opportunity to shape quality processes for development products, collaborate globally, and influence strategic decisions across the Development Supply Chain.
Key Responsibilities
Serve as the Fachtechnisch Verantwortliche Person (FvP) for development stage medicinal products and materials at Sandoz AG, Basel, in accordance with Swissmedic directive I-SMI.TI.17e.
Maintain and oversee the Arzneimittel and Swissmedic distribution licenses for development stage products.
Ensure that all aspects of handling and distribution comply with GDP regulations, Sandoz Quality Manual, and applicable legislation.
Lead the implementation and continuous improvement of the Quality Management System (QMS) for Sandoz AG.
Host regular management reviews and act as the main point of contact for market actions.
Provide expert GDP input during the preparation and negotiation of quality, supply, and commercial agreements.
Sign inter-affiliate Quality Agreements and other relevant documents on behalf of Sandoz AG.
Act as the Development QA GDP representative in global/local projects and audits.
Support local inspections and conduct self-inspections within the framework of the Quality System.
Maintain current knowledge of GxP and GDP regulations and trends.
Foster a strong quality culture within the Development Supply Chain team.
Minimum Requirements
Must reside within reasonable travel distance of the Sandoz AG site in Basel, as required by Swissmedic for the FvP role.
University degree in pharmacy (preferred), chemistry, biology, or a related life science field.
Fluent in German and English (written and spoken).
Minimum 5 years of experience in the pharmaceutical industry, ideally at least 1 year in a leading quality role
Proven experience in GMP and GDP, ideally for development stage medicinal products.
Strong communication skills and experience working with development sites, CROs, and international project teams.
Demonstrated leadership in pharmaceutical project management.
Must fulfill the requirements of Swissmedic directive I-SMI.TI.17e for FvP.
Good knowledge of the local language (German) as required by Swissmedic.
Why Join Us?
Be part of a global leader in generics and biosimilars.
Enjoy flexible hybrid work options and access global career development opportunities within a leading international pharmaceutical organization.
Influence strategic quality decisions in a dynamic development environment.
Collaborate with cross-functional teams across the globe.
Shape the future of sustainable healthcare.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!
Join us!
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and accommodation
Sandoz is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message
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Skills Desired
Agility, Audit Management, Business Acumen, Business Partnering, Collaboration, Communication Skills, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Goal-Oriented, Guideline, Inspection Preparedness, Leadership, Logical Thinking, Problem Solving Skills, Qa (Quality Assurance), Quality Decision Making, Quality Management, Regulation, Self-Awareness, Stakeholder Management, Teamwork, Technological ExpertiseSimilar Jobs
What We Do
Sandoz is the global leader in generic and biosimilar medicines.
Our Purpose is to pioneer access to medicines for patients globally. We are on a mission to drive innovation in the healthcare industry by freeing up resources sustainably and responsibly while continuing to address global health challenges such as antimicrobial resistance.
We are present in more than 100 countries and our medicines serve some 500 million people every year. We have two main global businesses: Generics - divided between standard generics and complex generics - and Biosimilars.
