Senior Analyst (Gene Therapy)

Location: Hybrid role based out of the San Diego, California office, with remote work permitted and in-person collaboration 3–4 days per week. Occasional travel of up to 20% is required.

Salary: $100,000–$126,500 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

• Provide QA oversight for internal and external QC laboratory operations supporting gene therapy programs.
• Serve as the QA point of contact for assigned products, stability programs, and laboratory functions.
• Review and approve analytical testing records, method validation documents, equipment qualification records, SOPs, deviations, investigations, CAPAs, change controls, and supplier notifications.
• Oversee OOS, OOT, and atypical laboratory investigations, including root cause analysis and quality impact assessments.
• Ensure compliance with cGMP, data integrity requirements, 21 CFR Part 11, Annex 11, and current regulatory filings.
• Support audits, regulatory inspections, supplier quality activities, laboratory metrics analysis, and continuous improvement initiatives.

Requirements

• Bachelor’s degree in Chemistry, Engineering, Life Sciences, or a related discipline.
• At least 5 years of Quality Assurance experience in the pharmaceutical or biotechnology industry, preferably supporting Quality Control operations.
• Experience supporting gene therapy and/or biologics is required.
• Strong knowledge of cGMP regulations and global laboratory compliance standards, including FDA, EMA, and ICH requirements.
• Experience with deviations, investigations, CAPAs, change controls, method validation oversight, data integrity, and risk-based decision-making.
• Knowledge of QC laboratory operations, analytical testing, laboratory systems, and Microsoft Office applications.

Nice to have

• Experience with HPLC/UPLC, CE-SDS, cell-based potency assays, ddPCR, ELISA, microbiology safety assays, or related methodologies.
• Familiarity with Veeva, LIMS, Chromeleon, BMRAM, or equivalent systems.
• Experience supporting internal or external audits, regulatory inspections, or supplier-related quality activities.

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, ESPP, and company-paid life and disability insurance.
• Learning resources, workshops, leadership programs, mentorship, and networking opportunities.
• Employee resource groups, service programs, and opportunities to volunteer and connect with colleagues.