Senior QA Compliance Director - GMP & Inspections

CSL; Bern; Hybrid; CHF 180,000 - 240,000; Full time

Job summary

CSL in Bern, Switzerland seeks an Associate Director, QA Compliance to lead the implementation and continuous improvement of the site's Quality Management System, ensuring alignment with CSL standards and GMP requirements. This senior leadership role oversees quality governance, inspection readiness, risk management, and regulatory compliance while partnering with global quality teams.

You will direct a team of quality professionals, drive KPI-based performance, oversee deviation management and

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality leadership

Regulatory compliance

GxP knowledge

Risk management

Stakeholder management

Education

Bachelor's degree in life sciences or related

Tools

Quality management systems

CAPA/Deviation management

Audit management

Inspection readiness

Job description

CSL in Bern, Switzerland seeks an Associate Director, QA Compliance to lead the implementation and continuous improvement of the site's Quality Management System, ensuring alignment with CSL standards and GMP requirements. This senior leadership role oversees quality governance, inspection readiness, risk management, and regulatory compliance while partnering with global quality teams.

You will direct a team of quality professionals, drive KPI-based performance, oversee deviation management and