Job Description

I'm partnering with a well-funded, pre-IPO biotech company in the Bay Area that’s developing cutting-edge therapies in a highly specialized space. As they prepare to scale their clinical programs, they’re looking to bring on a Director of Clinical GMP Quality to lead and evolve their quality systems through this critical phase of growth.

This is a high-impact role offering visibility, influence, and the chance to shape quality strategy in a science-driven environment. If you’re looking for an opportunity to build, lead, and make your mark at a nimble and ambitious biotech—this could be a strong fit.

What You'll Do:

• Lead Clinical GMP Quality activities including oversight of CMOs, QA batch review, and clinical material release
• Build and enhance quality systems in preparation for future growth and regulatory milestones
• Collaborate cross-functionally with Manufacturing, Regulatory, and Clinical teams to ensure compliance across early-stage programs
• Provide quality leadership during audits, inspections, and tech transfers
• Establish and maintain phase-appropriate GMP compliance for investigational products

What They're Looking For:

• 10+ years of experience in GMP Quality, with a strong track record supporting clinical-stage biotech or pharma
• Hands-on experience with batch record review, quality systems, and CMO oversight
• Ability to operate strategically and roll up your sleeves in a fast-paced environment
• Familiarity with pre-approval and early-phase regulatory expectations
• Based in the San Francisco Bay Area and available to be on-site at least 2 days per week

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