Senior Director, GCP & GPV Quality

📋 Description

• Lead GCP and GPV quality strategy across clinical programs.
• Maintain a phase-appropriate QMS for clinical and PV activities.
• Oversee audits, deviations, CAPAs, and safety reporting.
• Serve as primary contact for CROs/vendors on quality and safety.
• Drive inspection readiness and regulatory submissions.
• Lead and develop a small team of GCP/GPV professionals.

🎯 Requirements

• BS or advanced degree in biology, chemistry, life sciences.
• 10+ years in biotech/pharma with 6+ years in QC/GPV leadership.
• Strong knowledge of GCP, GPV, and EU regulatory expectations.
• Experience supporting both early- and late-stage programs.
• Proven inspection readiness and health authority interactions.
• Excellent communication, collaboration, and leadership in fast-growth environments.
• Nice to have: regulatory submissions experience.

🎁 Benefits

• Hybrid work arrangement (in-office 2-3 days/week).
• Opportunity to shape GCP/GPV functions in a growing biotech.
• Collaborative, fast-paced environment with growth opportunities.
• Competitive benefits package.
• Access to a modern HQ in Somerville, MA.