Metric Bio
A leading global CDMO is seeking a
Site Quality Head
to lead all Quality and Regulatory functions at its biologics manufacturing site. This role carries full accountability for site compliance, inspection readiness, and the Quality Management System while building a culture of quality across both clinical and commercial operations. Key Responsibilities Define and execute the Quality & Regulatory strategy for a biologics manufacturing site. Ensure full GMP / GxP compliance and inspection readiness with global regulatory agencies. Oversee all Quality Management System (QMS) processes including CAPA, deviations, change control, risk management, complaints, and batch release. Provide biologics quality leadership across drug substance, drug product, and fill/finish operations. Partner cross-functionally with Manufacturing, QC, Regulatory Affairs, and Supply Chain to ensure quality is embedded across site operations. Lead, mentor, and develop the Quality & Regulatory team, driving accountability and continuous improvement. Support global quality initiatives and align site practices with corporate standards. Qualifications & Experience Advanced degree in Life Sciences (Pharma, Chemistry, Biochemistry, Biotechnology, or related). 15+ years of progressive Quality/Regulatory leadership in the pharmaceutical industry; CDMO and biologics experience strongly preferred. Proven expertise in biologics manufacturing quality systems, including aseptic processing, fill/finish, and product release. Strong knowledge of GMP / GxP regulations with a track record of managing FDA, EMA, and other global regulatory inspections. Demonstrated success in building and leading high-performing Quality teams. This is an exciting opportunity to take on senior Quality leadership within a global CDMO, ensuring the highest standards of compliance and operational excellence at a biologics site.
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Site Quality Head
to lead all Quality and Regulatory functions at its biologics manufacturing site. This role carries full accountability for site compliance, inspection readiness, and the Quality Management System while building a culture of quality across both clinical and commercial operations. Key Responsibilities Define and execute the Quality & Regulatory strategy for a biologics manufacturing site. Ensure full GMP / GxP compliance and inspection readiness with global regulatory agencies. Oversee all Quality Management System (QMS) processes including CAPA, deviations, change control, risk management, complaints, and batch release. Provide biologics quality leadership across drug substance, drug product, and fill/finish operations. Partner cross-functionally with Manufacturing, QC, Regulatory Affairs, and Supply Chain to ensure quality is embedded across site operations. Lead, mentor, and develop the Quality & Regulatory team, driving accountability and continuous improvement. Support global quality initiatives and align site practices with corporate standards. Qualifications & Experience Advanced degree in Life Sciences (Pharma, Chemistry, Biochemistry, Biotechnology, or related). 15+ years of progressive Quality/Regulatory leadership in the pharmaceutical industry; CDMO and biologics experience strongly preferred. Proven expertise in biologics manufacturing quality systems, including aseptic processing, fill/finish, and product release. Strong knowledge of GMP / GxP regulations with a track record of managing FDA, EMA, and other global regulatory inspections. Demonstrated success in building and leading high-performing Quality teams. This is an exciting opportunity to take on senior Quality leadership within a global CDMO, ensuring the highest standards of compliance and operational excellence at a biologics site.
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