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Director, Clinical Quality Assurance

Cambridge, MA

Posted: 12/10/2018 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

Demeika Roberts

Demeika is known for her enthusiasm in working closely with hiring managers to assess their needs, creatively solve problems, and passionately help candidates find their “perfect fit” dream jobs.

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