QA Compliance Lead; m​/f​/d

Job Description

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.

• 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.

• 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, Swiss medic)
• 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

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.

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Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.