Senior GCP Auditor
Listed on 2026-10-02
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Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Regulatory Compliance Specialist
For our client, we are seeking a Senior GCP Auditor to join the team of a leader in the Pharmaceuticals & Biotech space. This role will help ensure clinical quality and compliance across trial operations, with a focus on Good Clinical Practice (GCP) standards in a regulated biotech environment. The Senior GCP Auditor will partner closely with internal teams and external vendors to strengthen quality systems, support audit readiness, and drive timely resolution of compliance issues.
The position is well suited for a detail-oriented professional who can balance documentation rigor with practical cross-functional problem solving.
Location:
Remote - US based candidates only, no visa sponsorship available. Compensation: $140,000 – $154,000 annually.
- Maintain and update the clinical trial quality management system
- Contribute to the development and review of SOPs and controlled documents
- Ensure compliance with ICH GCP E6 (R2) standards
- Manage the incident management program, including monitoring complaints and deviations
- Conduct vendor, supplier, and clinical trial site audits
- Prepare documentation for audit activities and follow-up resolutions
- Collaborate across teams to address GCP compliance issues
- Bachelor's or Master's degree in life sciences or engineering
- 7+ years of experience in a GCP-biologics or pharmaceutical setting with a Bachelor's degree, or 4+ years with a Master's degree
- CQA or similar audit certification preferred
- Experience with TMF or electronic document management systems preferred
- Strong analytical skills and attention to detail
- Comprehensive medical, dental, and vision plan options
- Employee Assistance Program (EAP)
- 401(k) retirement plan with company match
- Unlimited PTO for exempt employees
- 529 education savings program
- Wellness programs and employee discounts
Our client is an equal opportunity employer.
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