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QA Consultant

  • Job type: Contract
  • Location: Cambridge, Massachusetts
  • Salary: Competitive
  • Job reference: 321531/001_1559083249
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 28/05/2019

QA Consultant

A pharmaceutical company located in Cambridge, MA is looking to bring on a QA Consultant to their team for 6 months who will be responsible for developing, implementing, and overseeing the GCP, GLP, and GVP quality systems within the company.

Responsibilities:

  • Act as a subject matter expert within internal departments and external vendors such as CMOs and CROs

  • Assist with preparing and reviewing regulatory submissions for the FDA and other international health authorities

  • Head up a risk-based audit program that supports all clinical activities, as well as post approval development activities

  • Ensure FDA inspection-readiness

  • Develop and conduct training on all current compliance issues and regulations

Requirements:

  • B.S. with 10+ years of Quality experience in the pharmaceutical industry

  • GCP is a must, GVP is a plus

  • Prior experience conducting clinical site audits and clinical vendor audits

  • Prior experience in a leadership role

Accepting applicants at the Sr. Manager, Associate Director, and Director levels! The consultant is expected to start early June so don't miss your chance and apply now!

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