PpLocation: Stein, Switzerland /ph3Key Responsibilities /h3ulliProvide overall leadership and strategic oversight of Quality Compliance activities across the site in line with cGxP requirements. /liliAct as the senior quality authority for audits, inspections, and health authority interactions, ensuring sustained inspection readiness. /liliOwn and continuously develop the Quality Management System (QMS), including deviations, CAPAs, change control, and data integrity. /liliLead and govern GxP risk management, incident management, and compliance remediation activities. /liliEnsure effective regulatory and quality oversight of site activities, suppliers, and service providers. /liliDrive a strong quality culture, serving as a role model for integrity, accountability, and patient focus. /liliPartner closely with senior stakeholders across Manufacturing, Technical Operations, Regulatory, and Global Quality. /liliCoach and develop senior quality professionals, ensuring sustainable expertise and succession within the organization. /liliChampion Lean Leadership and operational excellence initiatives. /li /ulh3Essential Requirements /h3ulliMinimum 15 years of progressive experience in Quality Assurance and Compliance within a GMP‑regulated pharmaceutical or biotech environment. /liliProven track record in senior QA leadership roles, with clear accountability for compliance strategy and inspection outcomes. /liliDeep expertise in cGMP, Quality Systems, and regulatory frameworks (EMA, FDA, Swissmedic). /liliExtensive experience leading health authority inspections, audits, and complex remediation programs. /liliStrong credibility and executive presence when interacting with senior internal and external stakeholders. /liliDemonstrated ability to lead, influence, and challenge at senior management level. /liliUniversity degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related discipline. /liliFluent in English; German is a strong advantage for Switzerland. /li /ulh3Benefits and Rewards /h3pCommitment to Diversity and Inclusion / EEO paragraph. /ppAccessibility and Accommodation: 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 let us know the nature of your request and your contact information. Please include the job requisition number in your message. /p /p #J-18808-Ljbffr