Director of Quality Assurance

Job Title: Director of 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’ve partnered with an innovative oncology biotech company in San Diego that’s seeking a Director of Quality Assurance to establish and scale their global GxP compliance framework. This high-impact leadership role will oversee the design, implementation, and optimization of the Quality Management System across GLP, GCP, and GMP functions—supporting clinical and manufacturing efforts from preclinical through commercialization.

Opportunity Highlights:

  • Lead the implementation and evolution of GxP-aligned Quality Systems across the organization

  • Oversee quality strategies, risk mitigation planning, audit programs, and inspection readiness

  • Serve as a cross-functional quality leader with collaboration across Clinical Ops, CMC, Regulatory, and Preclinical functions

  • Manage CAPA programs, SOP development, and documentation for regulatory compliance

  • Act as a key liaison with external vendors (e.g., CROs, CDMOs, clinical sites) and lead quality agreement negotiations

  • Drive internal and external audit planning, inspection readiness, and FDA/EMA interface

  • Represent QA on cross-functional teams and partner with leadership on quality-driven initiatives

  • Support product release by managing document review, quality records, and data verification

  • Mentor QA team members and promote a culture of continuous quality improvement

Position Requirements:

  • Bachelor’s degree in life sciences or related field required

  • 7–10+ years of Quality Assurance experience in biotech or pharma; oncology/biologics preferred

  • Deep expertise in GxP regulations, ICH guidelines, and FDA/EMA regulatory requirements

  • Demonstrated success developing and leading Quality Systems across GLP, GMP, and GCP

  • Proven experience managing audits and engaging directly with global health authorities

  • Skilled in CAPA management, document control systems, and inspection readiness activities

  • Strong communicator and collaborator with the ability to influence cross-functional teams

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