Site Quality Head

Key Responsibilities

• Lead and develop site-wide Quality functions (QA, QC, Quality Engineering & Laboratories)
• Act as the site's Quality Management Representative, ensuring an effective and compliant QMS
• Drive regulatory compliance (FDA, cGMP, ISO 9001 / ISO 13485) and maintain audit readiness
• Partner with cross-functional teams (Manufacturing, Supply Chain, Regulatory) to deliver right-first-time quality performance
• Own quality systems including CAPA, deviations, change control, validation, complaints, and risk management
• Lead regulatory inspections and internal audits, ensuring strong outcomes and continuous improvement
• Implement and enhance a robust Quality Management System (QMS) aligned with global standards
• Embed a culture of continuous improvement, operational excellence, and quality ownership across the site

About You

• We are seeking a hands-on, strategic quality leader with:
• A Bachelor's degree in Science, Engineering, or related discipline (or equivalent experience)
• 7+ years' experience in Quality, Manufacturing, or Quality Engineering within: Pharmaceuticals, Biotechnology / Biopharma, Medical Devices, Other regulated manufacturing environments
• Strong knowledge of: ISO 9001 / ISO 13485, FDA regulations / cGMP / CFR requirements, Core quality systems (CAPA, validation, audits, risk management)
• Proven experience in leading teams and influencing cross-functional stakeholders
• A track record of improving quality systems, compliance, and operational performance