QA Compliance Lead (m/f/d)

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

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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)