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Job DescriptionJob Title: GCP Sr. Auditor Work Location: Paramus, NJContract Type: W2 OnlyWork Type: Hybrid (3 days/week at Office)Travel Required: Upto ~10% site travelWork Authorization: Only GC / US CitizensAbout 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 effectivelySupport preparation for regulatory inspections and site auditsAssist in quality improvement initiatives and continual enhancement of QA processes and practicesReview 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/PVMaintain audit schedules, metrics, and quality documentationMay mentor junior QA auditors and act as a subject matter resourceRequired Skills & Qualifications: (Must-Have)Bachelor’s degree in science, healthcare, life sciences, or related disciplineMinimum 5+ years in pharmaceutical or biotech industryStrong experience in GCP audits (internal/external) and clinical quality assuranceFamiliarity auditing CROs, CMOs, investigator sites, and clinical vendorsKnowledge of quality systems (QMS), SOPs, compliance documentation, CAPA processesAbility to audit clinical systems such as IRT, EDC, and other vendor systemsSolid understanding of global regulatory guidelines (FDA, EMA, ICH GCP)Strong report writing, communication, and stakeholder management skillsUp to 10% domestic/international travelPreferred Skills: (Nice-to-Have)Previous experience in neurology, psychiatry, or CNS therapeutic areaExperience in pharmacovigilance / safety auditsCertification in QA / auditingPhysical & Work Conditions:Office environment, with occasional site or vendor visitsAbility to travel as needed (≈10%)Must be comfortable working with and reviewing clinical and audit documentationOn-site presence required for key audit and inspection events