Senior Director, Quality Assurance (Gene Therapy)

Location: Hybrid role based in San Diego, California, with onsite work at least 3 days per week. Requires 30% domestic and international travel.

Salary: $214,000–$292,000 annual

Company

hirify.global is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.

What you will do

• Lead strategic and operational QA oversight for gene therapy development programs from toxicology through Phase 3 and commercialization.
• Ensure phase-appropriate GMP compliance for clinical trial materials, development-stage manufacturing, analytical activities, and quality systems.
• Manage and develop a team of 5–9 Quality professionals through coaching, feedback, and career development.
• Oversee deviations, CAPAs, change controls, protocols, reports, investigations, and root cause analysis.
• Provide QA oversight of CDMOs, testing laboratories, and other GxP vendors, including audits, quality agreements, risk assessments, and vendor qualification.
• Support process development, method validation and transfer, scale-up, regulatory submissions, and development QA SOPs.

Requirements

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related discipline; an advanced degree is strongly preferred.
• At least 15 years of relevant biopharmaceutical QA experience, including at least 10 years supporting development-stage gene therapy programs.
• Experience leading and developing high-performing QA teams in a fast-paced, matrixed environment.
• Deep knowledge of phase-appropriate quality systems, GMP regulations, ICH, EU Annexes, and ISO 13485/14971 requirements.
• Experience with CDMO, testing laboratory, audit, vendor, investigation, change control, and quality risk management activities.
• Experience supporting IND, IMPD, BLA/MAA submissions and proficiency with Microsoft Office and quality systems such as Veeva, TrackWise, or MasterControl.

Nice to have

• Advanced degree such as MS, PhD, or PharmD.
• ASQ CQA or CQE certification.
• Experience in a global development organization and familiarity with data trending or statistical analysis.

Culture & Benefits

• Medical, dental, vision, and mental health coverage with annual wellbeing reimbursement and Employee Assistance Program access.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration.
• 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
• Learning programs, LinkedIn Learning access, leadership development, mentorship, and networking opportunities.
• Employee resource groups, service and recognition programs, and volunteering opportunities.