Job Description
Job 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 May mentor junior QA auditors and act as a subject matter resource Required Skills & Qualifications: (Must-Have) Bachelors 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 Up to 10% domestic/international travel Preferred Skills: (Nice-to-Have) Previous experience in neurology, psychiatry, or CNS therapeutic area Experience in pharmacovigilance / safety audits Certification in QA / auditing Physical & Work Conditions: 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
5+ years