Katalyst Healthcares and Life Sciences is looking for GCP Auditor, Quality Assurance in Hackensack, NJ. This local job opportunity with ID 3662786727 is live since 2026-05-04 14:28:34.

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.

Responsibilities:

• 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.

Job Requirements / Qualifications:

• 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.
• bility to work with global clinical teams.
• 10% travel required.

Ideal Candidate Profile:

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