QA Compliance Lead (m/f/d)

Location: Stein, Switzerland

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 pro...