GCP Sr. Auditor, Quality Assurance
GCP Sr. Auditor, Quality Assurance
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Salary Not Disclosed
1 Vacancy
Job Description
Shift: 9.00AM-5.00PM
- The GCP Quality Assurance Sr. Auditor will report to the Director the GCP/PVG Quality Assurance.
- This position will be focused on ensuring GXP compliance with regulatory authorities driving and implementing the Company s compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment.
- The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits.
- This position will provide day to day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs CMOs investigator sites and all relevant vendors to support clinical trials.
- The Sr. Auditor of Quality Assurance will work with the QA and cross functional teams communicate with QA consultants and has contact with external auditees vendors partners and affiliates.
- The ideal candidate will have extensive GCP experience.
- This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies.
- They are based in Northern New Jersey and require the candidate to be on-site.
- Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance
- 5 years of pharmaceutical experience
- BS degree in scientific health care or related discipline
- Intensive GCP and safety background
- Experience with both internal and external process and systems audits
- Strong knowledge of development policies procedures and standards (SOPs QMS)
- Ability to work with global clinical teams in developing objectives for audits of clinical studies
- 10% Traveling required
- Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials.
- Plan and conduct audits of specific clinical processes based on risk.
- Perform clinical vendor audits along with various SMEs (IRT EDC etc.) to comprehensively assess all services provided by a vendor.
- Develop audit reports and distribute them to appropriate stakeholders.
- Own and manage related clinical vendor non-conformances.
- Review understand and audit clinical related regulations and guidelines (e.g. FDA regs GCP etc.).
- Collaborate with clinical sourcing supplier quality and clinical partnership to manage clinical vendors.
- Support the preparation coordination and participation of regulatory agency inspections.
- Participate in and support quality improvement projects.
Employment Type
Full Time
