QA Compliance Lead

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, 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