Vice President, Head of Quality
$285,000–$350,000 year
On-site · Watertown, Massachusetts, United States
Job Summary
Head of Quality is responsible for strategic and operational quality oversight across manufacturing, clinical operations, pharmacovigilance, and external partner activities throughout drug development. Will lead scalable, phase-appropriate Quality systems and governance to support clinical development, inspection readiness, manufacturing scale-up, and future commercialization. Partners with CMC, Regulatory, Clinical Operations, Clinical Supply, Technical Operations, and external partners to ensure compliance with global regulations and maintain quality, integrity, and patient safety. Key activities include audits of CMOs/CROs/CDMOs and PV vendors, leading Health Authority inspections, establishing and maintaining QMS, governing quality metrics and risk management, batch record review and release, QP collaboration, vendor oversight, deviation/CAPA/change control management, analytical documentation review, and ensuring QA input to CMC, scale-up, and clinical trials. Requires extensive QA leadership in FDA-regulated biotech/pharma environments, deep knowledge of GMP/GCP/GVP, and strong cross-functional collaboration. Salary range $285,000 - $350,000; location: Watertown, MA.
Required Qualifications
- 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
- Demonstrated leadership experience, including direct people management and building high-performing teams in a fast-paced biotech environment
- Experience supporting programs from clinical development through late-stage development and/or commercial readiness
- Strong working knowledge of global GxP requirements, including cGMPs (FDA/ICH), GCP, GCLP, GPV, and applicable international regulations and guidelines
- Experience in batch review and release for clinical phase products
- Experience authoring and reviewing SOPs, deviations, CAPAs, investigations, and change controls
- Experience performing and managing Quality audits and regulatory inspections
- Demonstrated understanding of issue management, risk management, and CAPA effectiveness in clinical and manufacturing environments
- Experience overseeing global vendor networks, including CROs, CMOs, CDMOs, and pharmacovigilance vendors
- Strong understanding of GMP requirements for drug development, manufacturing scale-up, and inspection readiness
- Working knowledge of oncology drug development preferred
- Strong ability to partner and collaborate effectively cross-functionally with Clinical Operations, Technical Operations, Regulatory, and other key stakeholders
- Excellent written and verbal communication skills with strong executive presence and influencing capabilities
- Ability to manage competing priorities and timelines in a fast-paced, evolving environment
- Strong problem-solving skills and ability to implement scalable process improvements
- Demonstrated commitment to quality, compliance, patient safety, and data integrity
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