Posted to MedZilla on 2/16/2020

Phaidon International

US-MA, Executive Director of R&D Quality Assurance 452431242290-MZ


Executive Director/Vice President of R & D Quality Assurance needed for top Biotechnology Company to Head the R&D Compliance and Process Division
  • Executive Director/Vice President | R&D Quality Assurance  
  • Boston | Massachusetts              
  • $200,000 - $250,000 + bonus + excellent benefits

My client, a global leading Biotech company, is looking for an Executive Director or Vice President of R &D Quality Assurance to head the R&D Compliance and Process Division of the business. The head of R&D QA will be responsible for the strategy, design, and implementation of an organization that conducts Clinical Research Audit and Compliance activities in accordance with GCP standards.

The company is a widely recognized Biotech company that is known for developing and delivering innovative medicines for patients with rare diseases and speciality diseases.

The Executive Director/Vice President of Quality Assurance will have the following responsibilities:


The selected individual will the key representative for R&D QA & Compliance at senior level meetings where key decisions regarding GCP compliance and risks will be discussed and decisions made. They will be responsible for the execution of the Master Audit Plan, Compliance support, Lead a team consistent with the organizations standards, and develop and manage the strategies for the preparation, hosting and response to regulatory agency inspections.


The ideal candidate will have the following skill set:
  • 15+ years experience
  • Proven people development and management skills
  • Proven track record of “turn-around” compliance improvement activities
  • Broad background in product development, clinical operations, regulatory compliance, and GCP Auditing
  • Experience with implementation of root cause analysis of audit observations

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