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 [email protected] 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
Role Requirements
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)
