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.
About The Role
Key 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, 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.
Essential 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, 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 progra