GCP Sr. Auditor
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Job Location:
Monthly Salary:
Experience Required:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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
Company Industry
IT Services and IT Consulting
Key Skills
- Auditing
- Time Management
- ICD-10
- Accounting
- Component evaluation
- Workers' Compensation Law
- SOX
- Microsoft Excel
- CPT Coding
- Internal Audits
- Medicare
- Bookkeeping
