GCP Auditor, Quality Assurance

Job Description

The GCP Quality Assurance Auditor reports to the Director of GCP/PVG Quality Assurance and is responsible for ensuring GxP compliance with regulatory authorities. The role focuses on implementing compliance directives, supporting quality management systems, and minimizing risk in a regulated pharmaceutical environment. The auditor conducts and participates in internal and external GxP audits, supporting Clinical Operations, Non-Clinical, Manufacturing, and Pharmacovigilance activities.

The position works closely with CROs, CMOs, investigator sites, vendors, and cross‑functional teams to support clinical trials. This opportunity is with a rapidly growing biopharmaceutical company specializing in Neurology and Psychiatry therapies.

• Plan and conduct global clinical process and vendor audits across clinical trials.
• Perform risk‑based audits of specific clinical processes.
• Conduct clinical vendor audits with SMEs (e.g., IRT, EDC).
• Develop and distribute audit reports to stakeholders.
• Own and manage clinical vendor non‑conformances (CAPAs).
• Review and audit compliance with FDA regulations, ICH‑GCP, and related guidelines.
• Collaborate with clinical sourcing, supplier quality, and clinical partnerships.
• Support regulatory agency inspections.
• Participate in quality improvement initiatives.

• 2+ years of pharmaceutical industry experience.
• Bachelor's degree in scientific, healthcare, or related discipline.
• Strong GCP and safety background.
• Experience with internal and external audits (process & systems).
• Strong knowledge of SOPs, QMS, policies, and procedures.
• Ability to work with global clinical teams.
• 10% travel required.

• Extensive GCP auditing experience.
• Strong communication skills with internal teams and external partners.
• Detail‑oriented with a risk‑based auditing mindset.