Senior Director, Quality Assurance

Senior Director, Quality Assurance

Company: Clinical-Stage Cell Therapy Biotechnology Company
Location: San Diego, CA | Onsite
Employment Type: Permanent

The Opportunity

Brio Resource Group is partnering with a clinical-stage biotechnology company advancing innovative cell-based therapies to identify a Senior Director, Quality Assurance.

This hands-on leadership position will oversee Quality Assurance across GxP functions, own the Quality Management System, and ensure clinical programs, manufacturing activities, and the supply chain remain compliant and inspection-ready. The successful candidate will balance pragmatic, phase-appropriate quality oversight with the strategic leadership required to scale the organization and support future commercialization.

Key Responsibilities

  • Define and execute the company’s Quality Assurance strategy in alignment with corporate objectives and global regulatory requirements.
  • Lead and develop the Quality organization across Quality Operations, Quality Systems, Validation, Supplier Quality, and Clinical Quality.
  • Own and administer the Quality Management System across GxP activities.
  • Maintain inspection readiness and accountability for regulatory audits, inspections, and compliance outcomes.
  • Provide quality oversight across product and process development, manufacturing, testing, validation, supply, and clinical-trial execution.
  • Review and approve protocols, reports, risk assessments, technical justifications, SOPs, policies, and other controlled documents.
  • Oversee deviations, CAPAs, change controls, investigations, qualification, validation, and risk-management activities.
  • Partner with Clinical, CMC, Regulatory Affairs, Supply Chain, Manufacturing, and external vendors.
  • Serve as an authorized Quality representative during GMP audits and health-authority inspections.
  • Develop and report quality metrics that identify compliance trends, emerging risks, and mitigation priorities.
  • Oversee third-party manufacturers, contractors, laboratories, and other regulated vendors.
  • Build scalable quality capabilities while promoting continuous improvement, accountability, and a company-wide quality culture.

Qualifications

  • Bachelor’s degree in life sciences or a related discipline; an advanced degree is preferred.
  • At least 10 years of progressive Quality Assurance experience within biotechnology or pharmaceuticals.
  • Deep cGxP expertise, particularly across GMP and GCP, with strong knowledge of global regulations and quality expectations.
  • Technical and regulatory experience with biologics, gene therapy, or cell therapy across clinical and commercial stages.
  • Demonstrated experience scaling quality operations, streamlining quality systems, and maintaining inspection readiness.
  • Strong knowledge of deviations, CAPAs, change control, investigations, validation, drug-substance manufacturing, and drug-product manufacturing.
  • Experience supporting regulatory submissions, product approvals, audits, and health-authority inspections.
  • Proven ability to lead, develop, and scale high-performing Quality teams.
  • Experience managing CMOs, CROs, suppliers, laboratories, and other third-party partners.
  • Strong judgment, problem-solving, negotiation, communication, and cross-functional leadership skills.
  • Ability to manage competing priorities and deliver results within a fast-paced biotechnology environment.
  • Willingness to travel up to 20%.

Why Consider This Opportunity?

This role offers the opportunity to lead the Quality function for an innovative clinical-stage biotechnology company, shape its quality strategy, prepare the organization for future regulatory and commercial milestones, and build the systems and capabilities required for continued growth.

A complete job description and additional company information will be provided following an initial résumé review.