Senior Director, Quality Assurance - Gene Therapy

Role Overview

The Senior Director Quality Assurance will lead Gene Therapy QA oversight for product programs from toxicology through Phase 3 and commercialization. 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.

What You Will Do

Provide strategic and operational Quality leadership for development programs from toxicology through Phase 3, ensuring compliance with GMPs and internal standards. Lead and develop a team of 5–9 Quality professionals supporting development programs; provide coaching, feedback, and career growth opportunities.

Why It Might Be a Fit

You have 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.

Requirements

• Minimum of a BS degree in Life Sciences, Chemistry, Engineering, or related discipline
• At least 15 years of relevant Quality Assurance experience in the biopharmaceutical industry
• 10 years supporting development-stage Gene Therapy programs
• Strong leadership skills with experience managing and developing high-performing QA teams
• Deep knowledge of phase-appropriate quality systems, regulatory requirements, and compliance expectations
• 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
• ASQ certifications (CQA, CQE) and prior experience in a global development organization are strongly preferred

Benefits

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