GCP Sr. Auditor
25 days ago
Paramus
Job DescriptionJob Title: GCP Sr. Auditor Work Location: Paramus, NJ Contract Type: W2 Only Work Type: Hybrid (3 days/week at Office) Travel Required: Upto ~10% site travel Work Authorization: Only GC / US Citizens About the Role: As the GCP Quality Assurance Senior Auditor, you will play a critical role in ensuring compliance with global GxP regulations, managing audits across clinical, nonclinical, and pharmacovigilance (PV) domains, and supporting high-integrity quality systems. You will report to the Director of GCP/PV Quality Assurance and will partner closely with clinical operations, vendor management, and cross-functional QA teams. Key Responsibilities: • Plan and lead internal and external GxP audits (clinical trials, vendor/CRO audits, investigator sites, CMOs, etc.), • Conduct risk-based audits of clinical processes and vendor systems (e.g. IRT, EDC), • Prepare detailed audit reports, issue non-conformances, and follow through on corrective / preventive actions (CAPAs), • Interface with stakeholders (vendors, partners, CROs, CMOs, investigators) to ensure audit findings are resolved effectively, • Support preparation for regulatory inspections and site audits, • Assist in quality improvement initiatives and continual enhancement of QA processes and practices, • Review and interpret clinical development and safety policies, SOPs, guidelines (e.g. ICH E6, GCP, applicable FDA/EMA regulations), • Provide QA support to cross-functional teams involved in clinical operations, nonclinical, and safety/PV, • Maintain audit schedules, metrics, and quality documentation, • Bachelor’s degree in science, healthcare, life sciences, or related discipline, • Minimum 5+ years in pharmaceutical or biotech industry, • Strong experience in GCP audits (internal/external) and clinical quality assurance, • Familiarity auditing CROs, CMOs, investigator sites, and clinical vendors, • Knowledge of quality systems (QMS), SOPs, compliance documentation, CAPA processes, • Ability to audit clinical systems such as IRT, EDC, and other vendor systems, • Solid understanding of global regulatory guidelines (FDA, EMA, ICH GCP), • Strong report writing, communication, and stakeholder management skills, • Previous experience in neurology, psychiatry, or CNS therapeutic area, • Experience in pharmacovigilance / safety audits, • Office environment, with occasional site or vendor visits, • Ability to travel as needed (≈10%), • Must be comfortable working with and reviewing clinical and audit documentation, • On-site presence required for key audit and inspection events