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QA Consultant

EPM Scientific Cambridge Contractor
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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!

 

Skills required

Sample Procedure
Quality Assurance
Performance Testing
Perform Inspection
Total Quality Management
Provide Technical Guidance
Apply to this job.
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Job ID: 321531/001

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EPM Scientific exists to enable exceptional careers around the world; we connect exceptional talent, with exceptional opportunities.

We believe that every professional should benefit from the advice of a trusted partner throughout their career.

We provide that partnership to mid to senior level professionals within Life Sciences through our network of micro-specialist consultants.

Our shared values of Ability, Character and Loyalty, underpin and drive the performance of every EPM Scientific consultant around the world.

Each team within EPM Scientific focuses on a specialist area of Life Sciences and within each team every consultant has a micro-specialist area of expertise, ensuring you gain a partner with knowledge that can immediately add value to your career.

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