Vice President of Quality

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Vice President, Head of QualityWe are seeking an experienced quality leader to oversee global quality strategy and operations for a biopharmaceutical organization. This role will be responsible for ensuring compliance with international regulatory standards (FDA, EMA, NMPA, ICH) while driving continuous improvement across quality systems and manufacturing processes. The ideal candidate will bring deep expertise in biologics and extensive experience within contract development and manufacturing (CDMO) environments.Key ResponsibilitiesLead and oversee quality assurance and quality control functions across clinical and commercial biologics manufacturing.Develop, maintain, and continuously improve a global Quality Management System (QMS) aligned with FDA, EMA, NMPA GMP requirements, and ICH guidelines.Ensure readiness for regulatory and client audits, including direct oversight of FDA and EMA inspections.Mentor and guide quality teams, fostering a culture of compliance, operational excellence, and continuous improvement.Stay current with evolving global regulations and proactively implement best practices.Partner with RandD, Manufacturing, Engineering, and Supply Chain to embed quality principles into all stages of product lifecycle management.Drive quality initiatives that enhance process robustness, reduce deviations, and improve product quality.QualificationsAdvanced degree in Life Sciences, Pharmacy, Engineering, or related field.15+ years of progressive quality leadership experience in biopharmaceuticals, with a strong preference for CDMO experience.Demonstrated expertise in biologics manufacturing and Biologics License Application (BLA) submissions (FDA/EMA).Proven track record managing global quality teams and complex regulatory interactions.Deep knowledge of cGMP, ICH guidelines, and global regulatory frameworks (FDA, EMA, NMPA).Strong problem-solving, communication, and leadership skills.Seniority level

Seniority level Not ApplicableEmployment type

Employment type Full-timeJob function

Job function Quality AssuranceIndustries Pharmaceutical ManufacturingReferrals increase your chances of interviewing at BioTalent by 2xInferred from the description for this job

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