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GCP QA Senior Manager

4 months ago

Cambridge, United States Meet Full time

We are partnering with a Massachusetts based Biotech to help them add a Manager of GCP Quality Assurance who will provide expertise and guidance on Good Clinical Practice (GCP), applicable regulations to clinical and nonclinical development teams to proactively identify compliance issues/risks and recommend mitigation.


Responsibilities

  • Provide expertise in GCP, compliance interpretation, consultation, training, and recommendations to clinical development functions and program teams
  • Lead investigations into significant quality issues, scientific misconduct and suspected serious breach of GCP or GLP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities, as appropriate. Manage deviations and CAPAs through completion
  • Identify and mitigate GCP activities and process improvement initiatives as requested by management
  • Work closely with Quality Assurance Head to ensure alignment and compliance with their Quality Systems
  • Provide risk identification/mitigation support for potential or identified quality issues
  • Appropriately escalate any quality/compliance issues to relevant leadership
  • Perform a quality assurance review of documents and data intended for regulatory submission


Qualifications


  • Bachelor’s degree in a scientific discipline is required. Advanced degree preferred.
  • 7+ years of clinical trial experience in a pharmaceutical, biotech, hospital setting, or a CRO is required with at least 5 years managing clinical trials.
  • Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development