SAN R&D Business Solutions
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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)
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
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
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Accounting/Auditing
Industries
Pharmaceutical Manufacturing
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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)
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
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
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Accounting/Auditing
Industries
Pharmaceutical Manufacturing
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