Senior Director of QA

I’m partnering with a clinical‑stage biotech preparing to advance its lead program into Phase II and looking to bring on a Senior Director of Clinical Quality Assurance to build and lead the Clinical QA function. This is a high‑impact role with broad ownership across GCP, GLP, GCLP, and GVP, supporting global clinical programs from early development through later stages.

• Build and lead the Clinical QA function, including internal team members and external partners
• Define and execute global, phase‑appropriate quality strategies across GCP, GLP, GCLP, and GVP
• Serve as a strategic QA partner to Clinical Operations, providing practical GxP guidance and risk‑based oversight
• Lead quality events, investigations, root cause analysis, and CAPA through closure
• Oversee domestic and international audits (sites, vendors, systems) and drive inspection readiness
• Establish quality metrics, KRIs/KQIs, and clear reporting to senior leadership
• Support IND submissions and interactions with global health authorities
• Partner cross‑functionally to ensure timelines, milestones, and quality commitments are met

• Bachelor’s degree in a scientific discipline
• 7+ years of clinical QA experience spanning Phase I through late‑stage development
• Strong working knowledge of global regulations (FDA, EMA, MHRA, PMDA)
• Proven success building and scaling risk‑based clinical quality systems
• Hands‑on experience with GxP processes including audits, documentation, change control, training, and CAPA
• Track record of operating in fast‑moving, resource‑lean environments
• Results‑driven mindset with the ability to prioritize, influence, and execute