QA Compliance Lead

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
• 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
• Champion Lean Leadership and operational excellence initiatives

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
• 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
• University degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related discipline
• Fluent in English; German is a strong advantage

About the Company

Novartis is an innovative medicines company working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease.