Senior GCP Auditor (Biotech)

Location: El Segundo, California, United States; the position may be onsite or remote as specified in the offer letter, with 25%–30% travel required.

Annual base pay: $140,000–$154,000 in national markets and $145,500–$160,000 in premium markets, plus discretionary bonus and equity eligibility.

Company

hirify.global is a publicly traded biotechnology company developing immunotherapies, cell therapies, cancer vaccines, and infectious-disease treatments.

What you will do

• Maintain and update the clinical trial quality management system in line with industry standards, ICH GCP, FDA regulations, and company procedures.
• Plan, coordinate, and conduct vendor, supplier, internal, for-cause, compliance, and clinical trial site audits.
• Prepare audit plans, reports, certificates, corrective action plans, and follow-up documentation.
• Manage complaints, deviations, CAPAs, audit findings, and related quality tracking systems.
• Review protocols, amendments, informed consent forms, pharmacy manuals, clinical study reports, and other trial documents.
• Support inspection readiness, regulatory inspections, training, and cross-functional GCP compliance activities.

Requirements

• Bachelor’s degree in life sciences or engineering with at least 7 years of experience in a GCP biologics or pharmaceutical environment, or a master’s degree with at least 4 years of relevant experience.
• Demonstrated understanding and application of ICH GCP E6 (R2).
• Strong planning, analytical, problem-solving, communication, and documentation skills.
• Ability to manage multiple functional areas, projects, deadlines, and flexible work schedules.
• Ability to work onsite or remotely as specified in the offer letter and travel 25%–30% when required.

Nice to have

• CQA or another audit certification.
• Experience with trial master files or electronic document management systems.

Culture & Benefits

• Collaborative environment with opportunities to work across clinical, regulatory, medical, pharmacovigilance, and data management functions.
• Professional development opportunities within a growing biopharmaceutical company.
• Medical, dental, vision, life, disability, and flexible spending account options.
• 401(k) retirement plan with company match, education savings program, and wellness resources.
• Paid time off, holidays, health pay, and additional employee support programs for eligible employees.