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