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Senior Manager, GCP Clinical Quality Assurance

  • Job type: Permanent
  • Location: New Jersey
  • Salary: $130000 - $160000 per annum
  • Job reference: ARTR021318528
  • Sector: Quality Assurance, EPM Scientific, Quality
  • Date posted: 13/02/2018
Senior Manager, GCP Quality Assurance
  • Medium sized pharmaceutical company
  • New Jersey
  • Base $130,000 - $160,000 + Excellent Bonus +Excellent Benefits
A medium sized global pharmaceutical company is urgently seeking a Senior Manager, GCP Quality Assurance, to join their team. This company has gained global recognition for its research-driven model and truly strives to put patients first. Our client’s pipeline spans over a wide range of therapeutic areas, including reproductive health, urology, gastroenterology, endocrinology, women’s health, and orthopedics.


This role will be responsible for conducting audits of the clinical trial sites, CRO’s, suppliers, protocols, and IB’s and reporting those findings to the company’s upper management.  


The Senior Manager, GCP Quality Assurance will be responsible for the following duties:
  • Conduct audits of Clinical trial sites, CROs, Suppliers etc.
  • Monitor and report audit trends locally
  • Manage Quality metrics and key process indicators and report to quality review boards
  • Establish and execute GCP training programs
  • Host local regulatory and health authority inspections
 

The Senior Manager, GCP Quality Assurance will have the minimum requirements:
  • Minimum of a B.S. in Life Sciences
  • 8 years experience within QA function; at least 5 years GCP auditing in a clinical QA environment
  • Strong knowledge of GCP QA and Compliance programs
  • Knowledge of ICH and ISO
 


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