Associate Director, Head QA Compliance

The Role

Quality systems and regulatory compliance are fundamental to ensuring patients can depend on safe, effective medicines. As Associate Director, QA Compliance, you will lead the implementation and continuous improvement of the site's Quality Management System, ensuring alignment with CSL standards and applicable GMP regulations. This is a senior leadership role with broad responsibility for quality governance, inspection readiness, risk management, and regulatory compliance, while partnering closely with global quality teams to drive consistency and excellence across the wider network.

Location: Bern, Switzerland  

Why It Matters

This role sits at the centre of the site's quality and compliance framework. You will help ensure the ongoing effectiveness of the quality systems that support licensed manufacturing operations, maintain regulatory compliance, and safeguard inspection readiness. Through leadership of quality risk management, change control, audit activities, and quality performance monitoring, you will play a key role in ensuring the site continues to meet the highest standards expected by health authorities, patients and the business.  

What You'll Be Responsible For

As Associate Director, QA Compliance, you will provide strategic and operational leadership for site quality compliance activities while leading a team of quality professionals. You will drive quality performance, oversee critical quality systems, and work across local and global functions to ensure consistent application of quality standards and continuous improvement initiatives.

• Lead the implementation and ongoing ownership of the site's Quality Management System in accordance with 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, quality risk management processes, including maintenance of the Quality Risk Register.
• Lead site preparation for regulatory inspections, customer audits, self-inspections, and internal audit activities while driving continuous 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 and direction to quality teams while partnering with Global Quality Systems and Compliance colleagues to strengthen and standardise quality processes across the network.

Experience Required

• Bachelor's degree or equivalent qualification in a relevant scientific or technical discipline.
• Significant experience, typically 10+ years, in quality assurance, quality systems, compliance, or a related pharmaceutical manufacturing environment.
• Deep expertise in pharmaceutical quality systems, quality management processes, GMP/GxP compliance, and regulatory requirements including ANNEX-1.
• Demonstrated experience managing health authority inspections e.g. Swissmedic, US FDA, NMPA China etc. associated regulatory interactions as well as customer audits.
• Strong knowledge of quality risk management, change control, Deviation Management, quality performance monitoring, and continuous improvement methodologies.
• Proven leadership, stakeholder management, and influencing skills, with experience working across global, matrixed, multicultural environments highly desirable.

Travel

Travel may be required to support collaboration with global quality and compliance teams, audit and inspection activities, and cross-functional initiatives across the network.