Senior Director Quality Assurance (Gene Therapy)

TL;DR

Senior Director Quality Assurance (Gene Therapy): Leading Gene Therapy QA oversight for product programs from toxicology through Phase 3 and commercialization with an accent on GMP compliance and strategic Quality leadership. Focus on managing risk, supporting regulatory readiness for complex pipelines, and overseeing CDMOs.

Location: Hybrid, based in San Diego, CA (must be onsite at least 3 days a week). 30% domestic and international travel required.

Salary: $214,000–$292,000 Annual

Company

A global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Provide strategic and operational Quality leadership for development programs from toxicology through Phase 3, ensuring GMP compliance.
• Serve as the Quality lead for GMP activities supporting clinical trial materials (DS/DP) in early and late-phase studies.
• Manage and develop a team of 5–9 Quality professionals, providing coaching and career growth.
• Oversee QA support for development-stage manufacturing, including review and approval of deviations, CAPAs, and change controls.
• Manage Quality oversight and relationships with contract development and manufacturing organizations (CDMOs) and GxP vendors.
• Support regulatory submissions (IND, IMPD, BLA) by contributing high-quality Quality input and documentation.

Requirements

• BS degree in Life Sciences, Chemistry, Engineering, or related discipline (Advanced degree MS, PhD, or PharmD strongly preferred).
• At least 15 years of QA experience in the biopharmaceutical industry, including 10+ years supporting development-stage Gene Therapy programs.
• Deep knowledge of phase-appropriate quality systems and regulatory requirements (21 CFR, ICH, EU Annexes, ISO 13485/14971).
• Proven success in QA oversight of CDMOs and testing labs, including audit and vendor management.
• Expertise in root cause analysis, investigations, change control, and Quality risk management.
• Proficiency in quality system tools such as Veeva, TrackWise, or MasterControl.

Nice to have

• ASQ certifications (CQA, CQE).
• Prior experience in a global development organization.
• Familiarity with data trending and statistical analysis.

Culture & Benefits

• Comprehensive medical, dental, vision coverage, and mental health support.
• Generous paid time off, fertility and family-forming benefits, and flexible work schedules.
• 401(k) plan with competitive company match and annual equity awards.
• Access to Company Learning Institute, including LinkedIn Learning and leadership programs.
• Employee resource groups and opportunities for volunteering and community connection.