Backed by GV.
About the role
The Vice President, Head of Quality Assurance provides strategic and operational leadership of GxP quality across manufacturing, laboratory, distribution, pharmacovigilance, and external partner activities from early clinical development through product approval. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- BA/BS in Science, Engineering, or a related discipline required, advanced degree (MS, PhD, PharmD, or equivalent) preferred
- 15+ years of Quality Assurance experience in an FDA-regulated biotech or pharmaceutical environment, with increasing levels of responsibility, including leadership of a quality function
- 5+ years of hands-on experience in one or more technical disciplines before transitioning into QA: Chemical Development/Manufacturing, Drug Product Development/Manufacturing, or Analytical Development
- Demonstrated success building and leading a quality organization that supports a clinical-stage pharmaceutical company
- Demonstrated success supporting programs through clinical development, experience with late-stage development, NDA/MAA submissions, and pre-approval inspections is a plus
- Mastery of global GxP requirements and applicable international regulations and guidelines
More about this role
The Vice President, Head of Quality Assurance provides strategic and operational leadership of GxP quality across manufacturing, laboratory, distribution, pharmacovigilance, and external partner activities from early clinical development through product approval. This individual will lead the continued development, implementation, and maintenance of scalable, phase-appropriate Quality systems and governance frameworks to support CMC development, clinical manufacturing, and inspection readiness, while building a foundation that can scale as the company’s programs advance toward registration and approval. The VP will partner with CMC, Clinical Operations, Regulatory, Biomarkers, Safety, and Clinical, and with external CDMO, CRO, and laboratory partners, to ensure compliance with applicable global regulations and to sustain a strong culture of quality, integrity, patient safety, and data integrity.
- Serve as the executive owner of quality, setting quality strategy and priorities in line with company objectives and development milestones, and representing Quality across the organization.
- Build, lead, and develop a quality assurance organization capable of supporting Treeline’s...
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