Associate Director, Clinical Quality Assurance

Job Title: Associate Director, Clinical Quality Assurance
Company: Biopharma
Location: San Diego, CA

Brio Resource Group is a Life Sciences Executive Search Firm committed to providing rare talent on an exclusive search basis to the Biopharma, Pharma, Device, and CRO industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging Biopharma companies offering life-changing therapies. Our many years of experience, subject matter expertise, comprehensive search process, and genuine passion to deliver rare talent defines Brio.

Position Overview:
We’re partnered with a clinical-stage biotech company in San Diego that’s pioneering novel immunotherapies for cancer treatment. They are seeking an Associate Director, Clinical Quality Assurance to lead quality initiatives across their clinical programs and ensure ongoing GCP compliance.

Opportunity Highlights:

  • Lead clinical quality activities across multiple trials and ensure compliance with GCP regulations and internal policies

  • Partner with clinical functions to embed quality practices from study design to execution

  • Oversee qualification and monitoring of GXP vendors including CROs and suppliers

  • Manage clinical audit programs (TMF, site, internal/external) and develop CAPAs and effectiveness checks

  • Provide quality input into clinical documents and agreements, including protocols, ICFs, and CSRs

  • Contribute to building scalable quality systems to support organizational growth

  • Interact with global health authorities and help build a culture of GCxP compliance in a startup environment

Position Requirements:

  • BS or MS degree in a scientific discipline required

  • 8+ years of experience in Clinical QA or broader pharmaceutical quality functions

  • Strong working knowledge of GCP, GLP, GMP, and relevant global regulations

  • Proven experience with clinical audits and vendor qualification

  • Excellent communication, collaboration, and organizational skills

  • Experience engaging with FDA, EMA, or other global health authorities

We welcome the opportunity to provide a full job description upon resume review.