Associate Director, GCP Excellence in Clinical Trials

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Job Description

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as an Associate Director, GCP Excellence in Clinical Trials based remotely reporting to the Director, GCP Excellence in Clinical Trials.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

GOALS:

• Implement and drive management of cross-functional study execution teams’ GCP inspection readiness and inspection preparation strategies, including proactive framework to facilitate process adherence, inspection-risk management, TMF oversight and proactive study team preparedness for audits and inspections.
• Partner with R&D Quality to serve the Clinical Sub-Team (CST)/Study Execution Team (SET) for end-to-end clinical trial delivery compliance and an aligned approach to inspection readiness strategy.
• Increase compliance effectiveness by driving implementation of global initiatives.
• Champion change and provide direct operational excellence strategies for clinical trial delivery projects and initiatives.

ACCOUNTABILITIES:

• Lead the development and implementation of GCP Excellence in Clinical Trials strategies to enable clinical trial functional areas and study teams to embed inspection readiness and process adherence into ways of working. 
• Partner with R&D Quality and GCP Compliance Management to develop GCP inspection strategy in support of submission planning and routine inspections.
• Drive strategies to facilitate and prepare Takeda Study Execution Team for GxP audits and inspections.
• Collaborate with study execution team leadership on adherence to clinical trial delivery procedures and development of effective mitigation and escalation strategies for inspection readiness issues or risks, and ensure effective flow of information between internal and external stakeholders.
• Proactively identify and lead assessments for process/therapeutic area/project risks and drive prioritization of quality deliverables for audits and inspections.
• Develop, lead and oversee strategies for GCP quality and inspection plans, collaborating with Global Development Compliance on CAPAs/ECs and with QA to ensure adherence to the plan.
• Oversee global and program aligned GCP Excellence in Clinical Trials support and associated operations ensuring optimal use of resources and cost efficiency.
• Ensure effective approach to actively lead Strategy Team Meetings and Core Team Meetings for assigned Inspection Readiness projects.
• Collaborate across GCP Excellence in Clinical Trials and with GCP Compliance Management to prepare and facilitate internal audits and regulatory inspections with study execution teams and functional leadership including but not limited to study team preparation, facilitating requests, managing responses and CAPA strategies.
• Partner with Quality Assurance to ensure appropriate audit scopes and clinical trial delivery participation; providing regular status updates to appropriate stakeholders and leadership.
• Monitor and provide