Senior Analyst, Quality Assurance (Analytical)

Location: San Diego, California, United States; full-time, in-person presence required. Occasional travel of up to 20% may be required.

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, assigned products, stability programs, and laboratory functions.
• Review and approve analytical testing documentation, raw material qualifications, method validation records, equipment qualification documents, and laboratory procedures.
• Review deviations, investigations, CAPAs, change controls, supplier notifications, OOS/OOT events, and atypical laboratory investigations.
• Assess laboratory quality risks, escalate high-risk or potentially regulatory-impacting issues, and provide risk-based recommendations.
• Ensure compliance with data integrity requirements, including 21 CFR Part 11 and Annex 11, and alignment with regulatory filings and product registrations.
• Support audits, regulatory inspections, supplier quality activities, continuous improvement, and audit readiness.

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 with 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, analytical method validation, data integrity, and laboratory systems compliance.
• Knowledge of QC laboratory operations, analytical testing, risk management, and tools such as HPLC/UPLC, CE-SDS, cell-based potency assays, ddPCR, ELISA, and microbiology safety assays.

Nice to have

• Experience with Veeva, LIMS, Chromeleon, BMRAM, or equivalent quality and laboratory systems.
• Familiarity with FMEA and other risk management tools.

Culture & Benefits

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