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