Senior Director Quality Assurance (Gene Therapy)

Location: Hybrid role based out of the San Diego, California office; onsite at least 3 days per week with 30% domestic and international travel required.

Salary: $214,000–$292,000 annual

Company

hirify.global is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.

What you will do

• Lead strategic and operational Quality Assurance 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.
• Oversee deviations, CAPAs, change controls, protocols, investigations, root cause analysis, and quality risk management.
• Provide Quality oversight for CDMOs and GxP vendors, including quality agreements, audits, vendor qualification, and ongoing checkpoints.
• Support process development, method validation and transfer, formulation, scale-up, and regulatory submissions including IND, IMPD, and BLA documentation.

Requirements

• BS degree in Life Sciences, Chemistry, Engineering, or a related discipline; an MS, PhD, or PharmD is 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; an advanced degree may substitute for experience.
• Strong leadership experience managing and developing high-performing QA teams in a fast-paced, matrixed environment.
• Deep knowledge of phase-appropriate quality systems, GMP regulations, ICH, EU Annexes, ISO 13485/14971, and clinical development compliance requirements.
• Experience with clinical manufacturing, analytical method development and validation, technology transfer, design controls, CDMO oversight, audits, and vendor management.
• Proficiency with Microsoft Office and quality system tools such as Veeva, TrackWise, and MasterControl.

Nice to have

• ASQ certifications such as CQA or CQE.
• Experience in a global development organization.
• Familiarity with data trending and statistical analysis.

Culture & Benefits

• Purpose-driven environment focused on patients, scientific progress, curiosity, and meaningful contributions.
• Medical, dental, vision, and mental health coverage, plus wellness reimbursement and an Employee Assistance Program.
• 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 Institute programs, LinkedIn Learning, leadership development, mentorship, employee resource groups, and service opportunities.