GCP Quality Assurance Auditor

JOB DESCRIPTION:

• The GCP Quality Assurance 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 Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants, and have contact with external auditees, vendors, partners, and affiliates. The ideal candidate will have extensive...