Associate Director, Risk Based Quality Management Operations

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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, Risk Based Quality Management Operations based remotely reporting to the Director, RBQM Operations.

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:

Risk Based Quality Management is responsible for implementing an enterprise-wide strategy for Risk Based Quality Management (RBQM) and Adaptive Monitoring (AM) to focus on critical-to-quality risks that drive data quality and site performance across the entire study lifecycle. 

This position reports to a Director of RBQM Operations and is responsible for successfully developing, in partnership with the RBQM director, implementing and coordinating RBQM procedures at the program, portfolio and asset level.  This position may also lead RBQM processes at the study level, including initial and recurring risk identification, assessment, centralized risk monitoring, and mitigation activities within the RBQM framework.

ACCOUNTABILITIES:  

• Supports development of RBQM processes at the program, portfolio, and asset levels to ensure risks and issues are appropriately cascaded from higher levels to studies and escalated from study level to program level when they may impact broader outcomes. 
• Contributes to the creation of a lessons learned framework to ensure insights from RBQM activities are captured and applied to future studies with similar characteristics. 
• May represent RBQM Operations at the Global Program Team (GPT) level for priority assets, providing strategic input and risk oversight. 
• Assists Directors with departmental responsibilities, including study tracking and resource allocation planning. 
• May support quality control activities for other RBQM Operational Leads, including TMF filing, study risk assessments, and centralized monitoring actions. 
• Contributes to the development and interpretation of program-level reports, extracting insights that inform and enhance RBQM processes across studies. 
• Supports process design and adoption of risk assessment tool. 
• May be responsible for the implementation of RBQM procedures for assigned studies including study risk assessment and centralized monitoring.
• Identifies and shares best practices, successes, case studies, failures, and process improvement opportunities to promote continuous improvement and consistency with RBQM processes.  
• Acts as a change agent, champion, subject matter expert and point of contact of RBQM methodology, leading study teams to understand and follow the best practices to achieve maximum benefit. 
• Supports inspections and regulatory interactions as it relates to Takeda’s adoption of RBQM framework.
• May perform line management of other (junior) staff within RBQM Operations.

EDUCATION AND EXPERIENCE: 

• 8 or more years of experience in the pharmaceutical or CRO industry.
• 3 or more years of experience in Risk Based Quality Management.
• 2 or more years managerial and supervisory experience.
• Robust understanding of the drug development process and clinical trial execution.
• Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP).
• Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions.
• Knowledge of RBQM IT systems or other data analytic systems.
• Demonstrated ability to analyze data, identify patterns and make recommendations fo