Associate Director, Head QA Compliance

About the role

As Associate Director, QA Compliance, you will lead the implementation and continuous improvement of the site's Quality Management System, aligned with CSL standards and applicable GMP regulations. This is a senior leadership role covering quality governance, inspection readiness, risk management and regulatory compliance, working closely with global quality teams. The position is based in Bern, Switzerland.

Key responsibilities

• Lead the implementation and ongoing ownership of the site's Quality Management System under CSL standards and global regulatory requirements.
• Maintain site manufacturing and establishment licence requirements and ensure continued GMP compliance.
• Chair the Site Change Control Panel and oversee deviation management and quality risk management, including the Quality Risk Register.
• Lead site preparation for regulatory inspections, customer audits, self-inspections and internal audits, driving inspection readiness.
• Monitor and improve quality performance through KPI management, trend analysis, Annual Product Reviews (APRs), Product Quality Reviews (PQRs) and Quality Management Reviews.
• Provide leadership to quality teams and partner with Global Quality Systems and Compliance colleagues to standardise quality processes across the network.

Required profile

• Bachelor's degree or equivalent in a relevant scientific or technical discipline.
• Significant experience, typically 10+ years, in quality assurance, quality systems, compliance or a related pharmaceutical manufacturing environment.
• Demonstrated experience managing health authority inspections (e.g. Swissmedic, US FDA, NMPA China) and customer audits.
• Proven leadership, stakeholder management and influencing skills; experience in global, matrixed, multicultural environments is highly desirable.

Required skills

• Pharmaceutical quality systems, GMP/GxP compliance and regulatory requirements including ANNEX-1.
• Quality risk management, change control, deviation management and quality performance monitoring.
• Continuous improvement methodologies.