AD, Preclinical & Clinical QA
Associate Director, Clinical, Pre-Clinical & Diagnostic QA
📍 Hybrid or Remote | Southern California HQ | 15-20% Travel
Join a biotech innovator advancing immune-based therapies that aim to reprogram the body's natural defenses to fight cancer and infectious diseases. This company is developing next-gen treatments that go beyond targeting disease.
About the Role
As Associate Director of Clinical, Pre-Clinical & Diagnostic QA, you'll be a key leader in the Development Quality Assurance team, driving compliance and quality oversight across global clinical trials. You'll help build and manage audit programs, lead inspection readiness efforts, and mentor cross-functional teams-all while shaping the systems that support groundbreaking research.
Key Responsibilities
- Lead GCP audit strategy and inspection readiness for global clinical trials.
- Manage and mentor QA staff across clinical and preclinical domains.
- Oversee supplier audits, CAPA processes, and quality metrics.
- Act as SME for GCP compliance across Clinical Ops, Regulatory, and Medical Affairs.
Qualifications
- Bachelor's or Master's in Life Sciences or Engineering.
- 6-8+ years in a GCP-regulated biotech or pharma sponsor environment.
- Experience in early-phase trials, regulatory hosting, and team leadership.
- Strong knowledge of FDA, ICH, and global GCP regulations.
- ASQ Certified Quality Auditor (CQA) preferred.
If you believe you'd be a good fit for this opening, please apply now.
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