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Head of Quality
3 months ago
- Biologics
- Cell & GeneHead of Quality required to work for a niche Cell & Gene Therapy Biotech.
Due to the success of their business, they're now growing their GMP manufacturing for late-stage clinical and commercial cell therapy.
They consistently collaborate with some of the biggest names in Life SciencesJOB TITLEHead of Quality / VP of QualityLOCATIONUSA / California / Bay Area / CASALARY$200K - $250K + bonus and packageROLE/DESCRIPTIONHighly visible role reporting directly to the C-Suite to establish and grow the quality and regulatory functions for the businessYou will spearhead, implement, and develop a quality management system (QMS)Oversee all QA activities throughout the product lifecycle, from early clinical to commercial phaseBe the primary liaison for the regulatory teams and ensure timely support of regulatory CMC filings, IND/IMPD and associated updates.
Communicate regulatory requirements to internal & external stakeholders, providing guidance on compliance strategies and regulatory risksConduct internal audits and oversee external audits from clients, regulatory agencies, and partnersRecruit and develop a high-performing team of quality professionalsREQUIREMENTSMinimum of 15 years experience in Biotech Quality Assurance & CMCBachelor's degree in a science disciplineRecent exposure to Cell & Gene therapy, CRISPR and/or GenomicsIn-depth knowledge of global regulations governing cell and gene therapy productsStrong leadership and communication skillsABOUT i- PHARM CONSULTINGi-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the USA, Europe and Asia Pac.
- Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and APPLYIf you would like to discuss this vacancy further, please call Principal Consultant David Fearnley on ### ####, or email .
- If this role is not suitable, David is also available to discuss other possible positions or answer any general questions regarding your career and the current market.
