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Director, Clinical Quality Assurance

Cambridge, MA

Posted: 03/18/2019 Job Category: Clinical: Quality Job Number: 2213

Our client is seeking a Director, Clinical Quality Assurance who will be responsible for GCP compliance as well as the initiation, conduct and follow-up of audits as assigned.

Responsibilities Include:
  • Development and oversight of the audit plan, which includes focus on GCP compliance and inspection readiness.
  • Plan and lead audits to determine compliance status and identify compliance risks.
  • Ensure that the audit plan is implemented; provide assurances that clinical studies are of the highest quality standard and are in compliance with the requirements of company SOPs, study protocols, relevant regulations and ICH guidelines/GCP regulations
  • Conduct QA reviews of project-related Clinical Development essential documents (e.g. protocols, amendments, case report forms, tables and listings, informed consents, investigator brochures, and Clinical Study Reports).
  • Ensure that audit results are formally and consistently recorded, reported, monitor trending and also ensure that corrective/preventive actions have been requested and documented effectively.

Requirements / Qualifications:
  • Bachelor’ s degree with 7-10 years of experience in Biotech or Pharma and 5+ years’ experience in Quality Systems related to GCP
  • Demonstrated experience conducting GCP audits and/or hosting regulatory authority inspections
  • In depth knowledge and understanding of drug development and the clinical trial process
  • In depth knowledge of current regulatory requirements and experience with regulations and guidelines
  • Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement
  • Understanding of domestic and international regulatory requirements

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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