QA Compliance Lead (m/f/d)

ph3Summary /h3 pLocation: Stein, Switzerland /p pWe 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. /p h3About The Role /h3 pKey responsibilities: /p ul liProvide overall leadership and strategic oversight of Quality Compliance activities across the site in line with cGxP requirements. /li liAct as the senior quality authority for audits, inspections, and health authority interactions, ensuring sustained inspection readiness. /li liOwn and continuously develop the Quality Management System (QMS), including deviations, CAPAs, change control, and data integrity. /li liLead and govern GxP risk management, incident management, and compliance remediation activities. /li liEnsure effective regulatory and quality oversight of site activities, suppliers, and service providers. /li liDrive a strong quality culture, serving as a role model for integrity, accountability, and patient focus. /li liPartner closely with senior stakeholders across Manufacturing, Technical Operations, Regulatory, and Global Quality. /li liCoach and develop senior quality professionals, ensuring sustainable expertise and succession within the organization. /li liChampion Lean Leadership and operational excellence initiatives. /li /ul h3Essential Requirements /h3 ul liMinimum 15 years of progressive experience in Quality Assurance and Compliance within a GMP‑regulated pharmaceutical or biotech environment. /li liProven track record in senior QA leadership roles, with clear accountability for compliance strategy and inspection outcomes. /li liDeep expertise in cGMP, Quality Systems, and regulatory frameworks (EMA, FDA, Swissmedic). /li liExtensive experience leading health authority inspections, audits, and complex remediation programs. /li liStrong credibility and executive presence when interacting with senior internal and external stakeholders. /li liDemonstrated ability to lead, influence, and challenge at senior management level. /li liUniversity degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related discipline. /li liFluent in English; German is a strong advantage for Switzerland. /li /ul h3Benefits Rewards /h3 pRead our handbook to learn about all the ways we’ll help you thrive personally and professionally. /p h3Commitment to Diversity and Inclusion / EEO paragraph /h3 pNovartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. /p h3Accessibility And Accommodation /h3 pApplicable 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 and 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