Site Head of Quality Assurance

About the role

The Site Head of Quality will lead both Quality Assurance and Quality Control functions at a leading pharmaceutical manufacturing site operating under strict GMP regulations. This senior position is responsible for ensuring product quality throughout the lifecycle and fostering a strong quality culture across the organization.

Key responsibilities

• Provide overall leadership for the site’s QA and QC activities, aligning with EU‑GMP requirements and corporate standards.
• Act as the primary quality representative, collaborating with Operations, Technical, Regulatory, and Corporate Quality teams.
• Oversee product quality from testing to batch disposition, making final release decisions.
• Lead, develop and mentor a team of quality professionals, promoting continuous improvement and GMP excellence.
• Ensure the effectiveness of the Quality Management System, including deviation management, CAPAs, change controls, investigations, risk assessments, and document control.
• Drive inspection readiness and manage responses to internal, customer and regulatory audit findings.
• Establish and monitor quality KPIs, identifying opportunities for operational and compliance enhancements.
• Support manufacturing and laboratory teams in addressing performance, compliance and product quality challenges.

Required profile

• Bachelor’s degree or higher in Pharmacy, Chemistry, Biology, Biotechnology, Engineering, Life Sciences or a related scientific discipline.
• Extensive experience in QA/QC or quality leadership within GMP‑regulated pharmaceutical or biotech environments.
• Proven track record managing and developing quality teams in a manufacturing setting.
• Strong knowledge of EU‑GMP regulations and quality systems.
• Demonstrated ability to oversee deviations, CAPAs, change controls, investigations, risk management and product release processes.
• Experience supporting regulatory inspections and maintaining continuous inspection readiness.
• Excellent stakeholder management and communication skills, with influence across cross‑functional teams and senior leadership.

Required skills

• EU‑GMP regulatory knowledge
• CAPA management
• Risk assessment and mitigation
• Quality Management System (QMS) operation
• Deviation and change control handling
• Product release and batch disposition