Senior Director, Quality Assurance - Gene Therapy

About the role

The Senior Director Quality Assurance will lead Gene Therapy QA oversight for product programs from toxicology through Phase 3 and commercialization. You will ensure phase-appropriate GMP compliance across manufacturing development, while providing strategic Quality leadership across internal teams and external partners. The role is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex, evolving pipelines. This is a supervisory position with 5-9 individual direct reports and would require you to be onsite at least 3 days a week. 30% domestic and international travel, required.

Responsibilities

• Provide strategic and operational Quality leadership for development programs from toxicology through Phase 3, ensuring compliance with GMPs and internal standards.
• Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP used in early and late-phase studies.
• Lead and develop a team of 5–9 Quality professionals supporting development programs; provide coaching, feedback, and career growth opportunities.
• Oversee QA support for development-stage manufacturing, analytical, and, including review and approval of deviations, CAPAs, change controls, and protocols/reports.
• Collaborate cross-functionally with CMC team, Regulatory, Clinical Operations, and Program Management to drive proactive Quality input into development programs.
• Provide Quality oversight of contract development and manufacturing organizations (CDMOs), and other GxP vendors used for clinical trial materials and services. Establish QA-QA relationships and checkpoints for critical CDMOs and service providers.
• Lead or support Quality Agreements, risk assessments, audits, and vendor qualification activities to ensure phase-appropriate compliance.
• Actively represent QA in technical development activities, including process development, method validation/transfer, formulation work, and scale-up.
• Drive phase-appropriate quality system improvements for development-stage programs.
• Support regulatory submissions (e.g., IND, IMPD, BLA sections) by reviewing or contributing Quality input and documentation.
• Create, maintain, and enhance Standard Operating Procedures governing Development QA activities.
• Support investigations and root cause analysis of product or process issues related to clinical manufacturing.

Requirements

• A minimum of a BS degree in Life Sciences, Chemistry, Engineering, or related discipline; advanced degree (MS, PhD, PharmD) strongly preferred.
• At least 15 years of relevant Quality Assurance experience in the biopharmaceutical industry, including at least 10 years supporting development-stage Gene Therapy programs; advanced degree may substitute for years of experience.
• Strong leadership skills with experience managing and developing high-performing QA teams in a fast-paced, matrixed environment.
• Deep knowledge of phase-appropriate quality systems, regulatory requirements (21 CFR Parts 210/211, 600s, 820, ICH, EU Annexes, ISO 13485/14971), and compliance expectations across clinical development.
• Demonstrated success in QA oversight of CDMOs, and testing labs, including audit and vendor management experience.
• Proven expertise in root cause analysis, investigations, change control, and Quality risk management.
• Direct experience with clinical manufacturing, analytical method development/validation, tech transfer, and design control processes.
• Experience supporting regulatory submissions (e.g., IND, IMPD, BLA/MAA) with high-quality documentation and Quality strategy input.
• Proficient in Microsoft Office and quality system tools (e.g., Veeva, TrackWise, MasterControl); familiarity with data trending/statistical analysis preferred.
• ASQ certifications (CQA, CQE) and prior experience in a global development organization are strongly preferred.

Qualifications

• Minimum of a BS degree in Life Sciences, Chemistry, Engineering, or related discipline; advanced degree (MS, PhD, PharmD) strongly preferred.
• At least 15 years of relevant Quality Assurance experience in the biopharmaceutical industry, including at least 10 years supporting development-stage Gene Therapy programs; advanced degree may substitute for years of experience.
• Strong leadership skills with experience managing and developing high-performing QA teams in a fast-paced, matrixed environment.
• Deep knowledge of phase-appropriate quality systems, regulatory requirements (21 CFR Parts 210/211, 600s, 820, ICH, EU Annexes, ISO 13485/14971), and compliance expectations across clinical development.
• Demonstrated success in QA oversight of CDMOs, and testing labs, including audit and vendor management experience.
• Proven expertise in root cause analysis, investigations, change control, and Quality risk management.
• Direct experience with clinical manufacturing, analytical method development/validation, tech transfer, and design control processes.
• Experience supporting regulatory submissions (e.g., IND, IMPD, BLA/MAA) with high-quality documentation and Quality strategy input.
• Proficient in Microsoft Office and quality system tools (e.g., Veeva, TrackWise, MasterControl); familiarity with data trending/statistical analysis preferred.
• ASQ certifications (CQA, CQE) and prior experience in a global development organization are strongly preferred.

Skills

• Leadership skills
• Quality assurance experience
• Regulatory compliance
• Root cause analysis
• Vendor management
• Quality system improvements
• Regulatory submissions
• Microsoft Office proficiency
• Quality system tools proficiency

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support
• Generous paid time off policies
• Fertility and family-forming benefits
• Caregiver support
• Flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match
• Annual equity awards
• Participation in Employee Stock Purchase Plan (ESPP)
• Company-paid life and disability insurance
• Employee Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Pay

$214,000.00-292,000.00 Annual

Schedule

Hybrid role based out of San Diego, CA office.