This role requires a true Clinical Quality professional with at least year years working in GCP and Clinical Trials.. The Associate Director, GCP Quality Assurance 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.. Advanced knowledge in the management of quality events and GCP deviations, inclusive of conducting robust root cause analysis and developing CAPA plans that mitigate risks to the company, to safety and data integrity. 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.. 8+ years of clinical trial experience in a pharmaceutical, biotech, hospital setting, or a CRO is required with at least 5 years managing clinical trials.

associate director

Title: Associate Director, GCP QualityStatus: Full-time, direct hire. Hybrid role: 3 days a week onsite in Lexington, MACompensation: $190,000 to $200,000 plus annual bonus and equity. This role requires a true Clinical Quality professional with at least year years working in GCP and Clinical Trials. The Associate Director, GCP Quality Assurance 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:<ul><li>Advanced knowledge in the management of quality events and GCP deviations, inclusive of conducting robust root cause analysis and developing CAPA plans that mitigate risks to the company, to safety and data integrity</li><li>Proven experience supporting clinical study protocol, Informed Consent, Clinical Study Report preferred</li><li>Provide expertise in GCP, compliance interpretation, consultation, training, and recommendations to clinical development functions and program teams</li><li>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</li><li>Identify and mitigate GCP activities and process improvement initiatives as requested by management</li></ul> Qualifications:<ul><li>Bachelor’s degree in a scientific discipline is required. Advanced degree preferred.</li><li>8+ years of clinical trial experience in a pharmaceutical, biotech, hospital setting, or a CRO is required with at least 5 years managing clinical trials.</li><li>Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development</li></ul>

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