Sr. QA Computer System Validation Mgr. (Biotech)

Location: Emeryville, California, United States

Base salary: $126,000–$145,000 per year

Company

hirify.global is a gene therapy company developing proprietary AAV vectors and targeted therapeutics for rare and serious diseases.

What you will do

• Provide QA oversight for GxP computer systems throughout validation, operation, change control, and retirement.
• Oversee computerized systems operated, hosted, or maintained by external partners and vendors.
• Review and approve CSV deliverables, IT change requests, nonconformance records, CAPAs, and other quality documentation.
• Provide day-to-day QA guidance for initial validation, steady-state activities, and controlled changes, with a focus on clinical systems.
• Serve as a subject matter expert on CSV, data integrity, FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable ICH guidelines.
• Support vendor qualification audits, inspection readiness, regulatory inspections, and improvements to QA and CSV procedures.

Requirements

• Bachelor’s degree in life sciences, computer science, business, or a related field.
• 5–7 years of experience in the biopharmaceutical industry and at least 4 years of QA CSV experience.
• Strong experience supporting computer systems used in clinical trials, including IRT, EDC, and eTMF systems.
• Thorough knowledge of computer system validation, computer software assurance, risk-based validation, and data integrity.
• Experience with enterprise, quality, laboratory, and clinical systems and with FDA, EMEA, MHRA, and other regulatory requirements.
• Excellent communication, stakeholder management, collaboration, attention to detail, and independent working skills.

Culture & Benefits

• Collaborative environment that encourages individual contributions and recognizes performance.
• Opportunities for career development and challenging work in gene therapy.
• Travel is required as needed and is expected to be less than 5%.
• Sedentary office-based working conditions with no substantial exposure to adverse environmental conditions.