Massachusetts Licensed GCP Compliance Director

A company is looking for an Associate Director, GCP Compliance. Key Responsibilities Direct and implement compliance management related to quality events and internal audits for clinical trial delivery Establish proactive risk-based compliance assessments and ensure robust CAPA/EC-related compliance assessments are completed Develop and report on key performance indicators and mitigation strategies for clinical trial delivery Required Qualifications Bachelor's Degree or international equivalent required; Life Sciences preferred 8 or more years of experience in the pharmaceutical industry and/or clinical research organization, including 6 or more years in compliance or clinical study management Global/international experience required, with collaboration skills across locations Experience in leading projects and coordinating with cross-functional teams Operational experience in clinical development with exposure to novel approaches in clinical development

Mar 3, 2025 - 21:50

A company is looking for an Associate Director, GCP Compliance. Key Responsibilities Direct and implement compliance management related to quality events and internal audits for clinical trial delivery Establish proactive risk-based compliance assessments and ensure robust CAPA/EC-related compliance assessments are completed Develop and report on key performance indicators and mitigation strategies for clinical trial delivery Required Qualifications Bachelor's Degree or international equivalent required; Life Sciences preferred 8 or more years of experience in the pharmaceutical industry and/or clinical research organization, including 6 or more years in compliance or clinical study management Global/international experience required, with collaboration skills across locations Experience in leading projects and coordinating with cross-functional teams Operational experience in clinical development with exposure to novel approaches in clinical development