Senior Director of Quality

About the role

The Senior Director of Quality will lead the Quality function at a key manufacturing site for a leading CDMO in France. Reporting to executive leadership, you will shape and execute the site’s Quality strategy, ensuring the highest standards of GMP compliance, regulatory excellence, and operational performance.

Key responsibilities

• Develop and implement the site’s Quality strategy aligned with business objectives and global regulatory requirements.
• Provide leadership across Quality Assurance, Quality Control, Compliance, Validation, and Quality Systems.
• Ensure full compliance with cGMP, FDA, EMA, and other international standards.
• Lead regulatory inspections, customer audits, and corporate quality assessments.
• Drive continuous‑improvement initiatives and strengthen quality systems.
• Partner with Manufacturing, Technical Operations, Engineering, Regulatory Affairs, and Supply Chain to support performance and delivery.
• Oversee investigations of deviations, CAPAs, change controls, complaints, and risk‑management activities.
• Develop and mentor a high‑performing Quality leadership team.
• Monitor quality metrics, identify trends, and implement strategic improvements.
• Support new product introductions, technology transfers, and commercial manufacturing while maintaining quality standards.
• Act as primary quality representative for key customer relationships.

Required profile

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Biotechnology or related field; advanced degree preferred.
• Significant senior leadership experience in Quality within pharmaceutical, biotechnology or CDMO environments.
• Strong knowledge of cGMP, FDA, EMA, ICH guidelines and international regulatory requirements.
• Proven success leading regulatory inspections and customer audits.
• Experience managing Quality Assurance, Quality Control, Compliance and Quality Systems in a GMP‑regulated setting.
• Demonstrated ability to develop high‑performing teams and drive continuous improvement.

Required skills

• cGMP compliance
• FDA regulatory knowledge
• EMA regulatory knowledge
• ICH guideline expertise
• Regulatory inspection leadership
• Validation processes
• Quality systems management
• CAPA handling
• Change control procedures
• Risk management