GCP Auditor, Quality Assurance

Katalyst Healthcares and Life Sciences Hackensack, NJ Open
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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.
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