GCP Sr. Auditor

JOB DESCRIPTION :

• 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 Companys 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

RESPONSIBILITIES :

QUALIFICATIONS :