Role Summary
Associate Director, GCP Compliance based in Cambridge, MA. Directs and drives the implementation of compliance management related to quality events and internal audits for clinical trial delivery functions, establishes proactive risk-based compliance assessments, and reports KPI-driven mitigation strategies to leadership. Responsibilities
Direct and drive the implementation of compliance management related to quality events and internal audits for clinical trial delivery functions including the identification and development of applicable processes and tools Establish and lead proactive risk-based compliance assessments for clinical trial delivery functions and ensure completion of robust CAPA/EC-related compliance assessment Develop and report to leadership on key performance indicators and mitigation strategies for clinical trial delivery Oversee and manage quality events/deviations including root cause analysis, CAPA development and implementation, effectiveness check tracking, and non-compliance reporting Facilitate clinical trial delivery internal audits with study teams and functional areas including study team preparation, audit requests, responses and CAPA development and implementation; partner with Quality Assurance to ensure appropriate audit scopes Lead clinical trial functional areas and study teams on GCP compliance and liaise with study execution teams on compliance to procedures and effective mitigation/escalation strategies Proactively identify process/therapeutic area/project risks and develop/lead assessments to address compliance Advise process owners and functional areas on mitigation and escalation strategies for projects to address risks and issues Develop, lead and oversee compliance assessments to address GCP Quality Plan, CAPAs/ECs and liaise with QA to ensure adherence Engage and build relationships with trial delivery functions, R&D QA, and stakeholders on performance metrics, analytics and reporting for GCP compliance Identify, develop, and track KPIs, metrics and dashboards to monitor process quality and compliance Train, coach and mentor supervised employees to create a culture that attracts and develops innovative thinkers; act as a role model for Takeda’s values Qualifications
Bachelor’s Degree or international equivalent required; Life Sciences preferred 8+ years' experience in the pharmaceutical industry and/or clinical research organization, including 6+ years in compliance or clinical study management Experience in leading projects and coordinating collaboration with cross-functional teams Global/international experience required, including ability to collaborate with colleagues in other locations Operational experience in clinical development with exposure to novel approaches in clinical development Skills
Strong strategic thinking, planning, execution, and communication skills Ability to build relationships with internal stakeholders and lead cross-functional initiatives Education
Bachelor’s Degree or international equivalent required; Life Sciences preferred
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Associate Director, GCP Compliance based in Cambridge, MA. Directs and drives the implementation of compliance management related to quality events and internal audits for clinical trial delivery functions, establishes proactive risk-based compliance assessments, and reports KPI-driven mitigation strategies to leadership. Responsibilities
Direct and drive the implementation of compliance management related to quality events and internal audits for clinical trial delivery functions including the identification and development of applicable processes and tools Establish and lead proactive risk-based compliance assessments for clinical trial delivery functions and ensure completion of robust CAPA/EC-related compliance assessment Develop and report to leadership on key performance indicators and mitigation strategies for clinical trial delivery Oversee and manage quality events/deviations including root cause analysis, CAPA development and implementation, effectiveness check tracking, and non-compliance reporting Facilitate clinical trial delivery internal audits with study teams and functional areas including study team preparation, audit requests, responses and CAPA development and implementation; partner with Quality Assurance to ensure appropriate audit scopes Lead clinical trial functional areas and study teams on GCP compliance and liaise with study execution teams on compliance to procedures and effective mitigation/escalation strategies Proactively identify process/therapeutic area/project risks and develop/lead assessments to address compliance Advise process owners and functional areas on mitigation and escalation strategies for projects to address risks and issues Develop, lead and oversee compliance assessments to address GCP Quality Plan, CAPAs/ECs and liaise with QA to ensure adherence Engage and build relationships with trial delivery functions, R&D QA, and stakeholders on performance metrics, analytics and reporting for GCP compliance Identify, develop, and track KPIs, metrics and dashboards to monitor process quality and compliance Train, coach and mentor supervised employees to create a culture that attracts and develops innovative thinkers; act as a role model for Takeda’s values Qualifications
Bachelor’s Degree or international equivalent required; Life Sciences preferred 8+ years' experience in the pharmaceutical industry and/or clinical research organization, including 6+ years in compliance or clinical study management Experience in leading projects and coordinating collaboration with cross-functional teams Global/international experience required, including ability to collaborate with colleagues in other locations Operational experience in clinical development with exposure to novel approaches in clinical development Skills
Strong strategic thinking, planning, execution, and communication skills Ability to build relationships with internal stakeholders and lead cross-functional initiatives Education
Bachelor’s Degree or international equivalent required; Life Sciences preferred
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