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Manager Clinical Quality (GCP/GLP)

  • Job type: Permanent
  • Location: Bridgewater, New Jersey
  • Salary: Negotiable
  • Job reference: 283091/006_1555369197
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 15/04/2019

Manager Clinical QA (GCP/GLP)

Northern, NJ

An Innovative pharmaceutical company is currently seeking a Manager Clinical QA to join its rapidly expanding team. This company was founded back in 2015, and already has in indication in phase 3 of clinical trials! This newly created position will give you the ability to join a company with tremendous amounts of growth potential. If you are looking to expand your career in the clinical QA area than don't hesitate to apply!

The Manager Clinical QA will have the following responsibilities:

  • Perform GCP/GLP qualification audits of CROs and Vendors (CROs, Test Facility & Laboratories)

  • Perform GCP/GLP audits including audits of clinical investigator sites, clinical trial master files, contributing scientist reports, clinical summary reports, and final reports

  • Act as a technical resource to resolve GCP/GLP issues based on knowledge of regulations, guidelines, and relevant SOPs

  • In partnership with Clinical and Preclinical Operations, provide quality oversight of internal and external clinical and preclinical activities

  • Collaborate with Clinical and preclinical functions to ensure compliance with all applicable regulations and standards

  • Provide support for the preparations for regulatory inspections of our offices and its CROs as necessary

  • Provide support and revise as needed, an effective GCP/GLP training program

  • Provide support for continuous improvement of QA systems and SOPs

  • Proactively identify quality issues/discrepancies; communicate, and effectively resolve issues in collaboration with internal and external partners

The ideal candidate will have:

  • Experience with GCP/GLP audits

  • 5 years QA experience

  • Bachelors degree in a related discipline

Compensation:

Competitive Base + Targeted Bonus + Stock + Healthcare + 401k

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