Senior Director, Quality Assurance - Gene Therapy

Location: Hybrid role based out of the San Diego, California office, United States

Company

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

What you will do

• Provide strategic and operational Quality leadership for development programs from toxicology through Phase 3.
• Lead GMP activities supporting clinical trial materials, including drug substance and drug product for early- and late-phase studies.
• Lead and develop a team of 5–9 Quality professionals through coaching, feedback, and career development.
• Oversee QA support for development-stage manufacturing and analytical activities, including deviations, CAPAs, change controls, protocols, and reports.
• Provide Quality oversight for CDMOs and other GxP vendors, including quality agreements, risk assessments, audits, and vendor qualification.
• Support technical development, regulatory submissions, SOP development, investigations, root cause analysis, and quality system improvements.

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 Quality Assurance experience in the biopharmaceutical industry, 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, 21 CFR Parts 210/211, 600s, 820, ICH, EU Annexes, and ISO 13485/14971.
• Experience with clinical manufacturing, analytical method development and validation, technology transfer, design controls, investigations, change control, and Quality risk management.
• Experience supporting regulatory submissions and using quality systems such as Veeva, TrackWise, or MasterControl.

Nice to have

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

Culture & Benefits

• Medical, dental, vision, and mental health coverage.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) plan with company match, annual equity awards, employee stock purchase plan, and company-paid life and disability insurance.
• Access to learning programs, LinkedIn Learning, leadership development, mentoring, and networking opportunities.
• Employee resource groups, service programs, recognition programs, and opportunities to volunteer and give back.