Backed by GV.
About the role
The Head of Quality Assurance is responsible for providing strategic and operational quality assurance oversight for clinical operations, clinical development, pharmacovigilance, and manufacturing and external partner activities across all phases of drug development, product launch, and commercialization.
What they're looking for
- BA/BS in Science, Engineering, or related discipline required, advanced degree (MS, PhD, PharmD, or equivalent) preferred
- Minimum of 10+ years of Quality Assurance experience in an FDA-regulated Biotech or Pharmaceutical environment with increasing levels of responsibility, with substantial experience in clinical/GCP quality
- Demonstrated success in building and leading a clinical quality organization capable of supporting a clinical/early commercial small pharmaceutical company
- Demonstrated success in supporting programs from clinical development through commercial readiness and lifecycle management
- Mastery of global GxP requirements, with deep expertise in GCP (ICH E6, FDA, EMA) and working knowledge of GCLP, GPV, cGMPs, and applicable international regulations and guidelines
- Expertise overseeing quality aspects of global vendor networks, particularly CROs and clinical sites, and pharmacovigilance vendors, working knowledge of CMO/CDMO oversight
More about this role
The Head of Quality Assurance is responsible for providing strategic and operational quality assurance oversight for clinical operations, clinical development, pharmacovigilance, and manufacturing and external partner activities across all phases of drug development, product launch, and commercialization.
This individual will lead the continued development, implementation, and maintenance of scalable, phase-appropriate Quality systems and governance frameworks to support clinical development, inspection readiness, commercialization activities, and commercial product lifecycle management, with particular emphasis on GCP compliance and clinical trial quality oversight.
The Head of Quality will work cross-functionally with Regulatory, Clinical Operations, Clinical Development, Pharmacovigilance, and Technical Operations as well as external CROs, clinical sites, CMO/CDMOs, and PV partners, to ensure compliance with applicable global regulations and to maintain a strong culture of quality, integrity, patient safety, and data integrity.
- Build, lead, and manage a quality assurance team capable of supporting the company's growing global clinical and technical development activities...
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