QA Compliance Lead (m/f/d)

Summary Location: Stein, Switzerland We are seeking a highly senior Quality Assurance Compliance leader to safeguard and continuously strengthen our GMP compliance landscape in Switzerland. This role is designed for an experienced quality authority who brings deep regulatory credibility, strategic oversight, and confident leadership in complex, regulated environments. About the Role Key responsibilities: Provide overall leadership and strategic oversight of Quality Compliance activities across the site in line with cGxP requirements Act as the senior quality authority for audits, inspections, and health authority interactions, ensuring sustained inspection readiness Own and continuously develop the Quality Management System (QMS), including deviations, CAPAs, change control, and data integrity Lead and govern GxP risk management, incident management, and compliance remediation activities Ensure effective regulatory and quality oversight of site activities, suppliers, and service providers Drive a strong quality culture, serving as a role model for integrity, accountability, and patient focus Partner closely with senior stakeholders across Manufacturing, Technical Operations, Regulatory, and Global Quality Coach and develop senior quality professionals, ensuring sustainable expertise and succession within the organization Champion Lean Leadership and operational excellence initiatives. Essential Requirements : Minimum 15 years of progressive experience in Quality Assurance and Compliance within a GMP‑regulated pharmaceutical or biotech environment Proven track record in senior QA leadership roles, with clear accountability for compliance strategy and inspection outcomes Deep expertise in cGMP, Quality Systems, and regulatory frameworks (EMA, FDA, Swissmedic) Extensive experience leading health authority inspections, audits, and complex remediation programs Strong credibility and executive presence when interacting with senior internal and external stakeholders Demonstrated ability to lead, influence, and challenge at senior management level University degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related discipline Fluent in English; German is a strong advantage for Switzerland Benefits & Rewards Commitment to Diversity and Inclusion / EEO paragraph Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Accessibility and Accommodation: Applicable Novartis 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, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message . Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally. Read our handbook (PDF 30 MB) Quality Operations Switzerland Job ID REQ-10074385 QA Compliance Lead (m/f/d) Apply to Job