Senior Analyst (Gene Therapy)

Location: San Diego office; full-time, in-person presence required. Occasional travel of up to 20%.

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 of internal and external QC laboratory operations supporting gene therapy programs.
• Act as the QA point of contact for assigned products, stability programs, and laboratory functions.
• Review and approve analytical testing records, method validation documents, equipment qualifications, SOPs, deviations, investigations, CAPAs, and change controls.
• 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, and continuous improvement initiatives.

Requirements

• Bachelor’s degree in Chemistry, Engineering, Life Sciences, or a related discipline.
• 5+ years of Quality Assurance experience in the pharmaceutical or biotechnology industry, preferably supporting QC operations.
• Required experience with gene therapy and/or biologics.
• Strong knowledge of cGMP regulations and FDA, EMA, and ICH laboratory compliance standards.
• Experience with deviations, investigations, CAPAs, change controls, method validation, risk management, and data integrity.
• Understanding of QC laboratory operations, analytical testing techniques, and systems such as Veeva, LIMS, Chromeleon, or BMRAM.

Culture & Benefits

• Medical, dental, and vision coverage with mental health support and wellbeing reimbursement.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible 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, workshops, mentorship, networking, employee resource groups, and service programs.