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Associate Director/Director, GCP Quality

Company: Agios Pharmaceuticals Inc
Location: Cambridge
Posted on: April 6, 2021

Job Description:

Associate Director/Director, GCP Quality Location Agios Pharmaceuticals HQ Job Code 1520 # of openings 1 Associate Director/Director, GCP Quality Agios ( is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development. Agios Pharmaceuticals is seeking a dynamic Associate Director/Director, GCP Quality. The Associate Director/Director, GCP Quality will conduct audits (site, vendor & internal process audits), provide Quality GCP consultation to clinical teams, lead inspection readiness activities,-- and provide direction to Agios stakeholders regarding GCP related activities/issues. Key Responsibilities

  • Serve as the GCP Quality representative for clinical study teams (CTWGs)
  • Provide ICH/GCP guidance and clinical compliance knowledge to the CTWGs, inclusive of supporting risk identification/management, investigation/CAPA activities, and responses to internal and external audit findings
  • Assist in the review and revision of Clinical Development and QA SOPs
  • 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)
  • Plan and lead audits to determine compliance status and identify compliance risks internally, at CROs, vendors and clinical sites
  • Ensure that audit results are formally and consistently recorded, reported, trended
  • Ensure that corrective/preventive actions have been identified, documented and are effective
  • Provide support for Health Authority inspections including conducting pre-inspection audits of sites--
  • Conduct QA audits of Regulatory submission
  • Support Quality management initiatives and Quality improvement plans for QA and defined business
  • Provide oversight of QA consultants performing audits
  • Conduct GCP training--
  • Bachelor's Degree in a scientific discipline
  • 10+ years of experience in the pharmaceutical industry, including 7+ years in GCP Quality.
  • Knowledge and experience in the applicable GCP regulations, including ICH Guidelines, E6 R(2)
  • In-depth knowledge of drug development processes.
  • Knowledge in the conduct and reporting of Heath Authority inspections and the translation of findings into corrective action.

Keywords: Agios Pharmaceuticals Inc, Cambridge , Associate Director/Director, GCP Quality, Executive , Cambridge, Massachusetts

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