Associate Director, Risk Quality Management Operations

Overview

Associate Director, Risk Based Quality Management Operations. This role is remote and reports to the Director, RBQM Operations. The organization focuses on transforming the pharmaceutical industry through R&D leadership and values-based work. The position contributes to the RBQM framework and adaptive monitoring to focus on critical-to-quality risks that drive data quality and site performance across the study lifecycle.

• Develop RBQM processes at the program, portfolio, and asset levels, ensuring risks and issues are cascaded appropriately and escalated when they may impact broader outcomes.
• Contribute to a lessons learned framework to capture insights from RBQM activities and apply them to future studies with similar characteristics.
• May represent RBQM Operations at the Global Program Team level for priority assets, providing strategic input and risk oversight.
• Assist Directors with departmental responsibilities, including study tracking and resource allocation planning.
• Support quality control activities for other RBQM Operational Leads, including TMF filing, study risk assessments, and centralized monitoring actions.
• Contribute to the development and interpretation of program-level reports, extracting insights that inform and enhance RBQM processes across studies.
• Support process design and adoption of risk assessment tools.
• May be responsible for implementing RBQM procedures for assigned studies, including study risk assessment and centralized monitoring.
• Identify and share best practices, successes, case studies, failures, and opportunities to promote continuous improvement and consistency with RBQM processes.
• Act as a change agent, champion, subject matter expert and point of contact for RBQM methodology; lead study teams to follow best practices to achieve maximum benefit.
• Support inspections and regulatory interactions related to Takeda’s adoption of the RBQM framework.
• May perform line management of junior staff within RBQM Operations.

• 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 of managerial and supervisory experience.
• Robust understanding of the drug development process and clinical trial execution.
• Knowledge of 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, and Corrective Actions Preventive Actions.
• Knowledge of RBQM IT systems or other data analytic systems.
• Demonstrated ability to analyze data, identify patterns and make improvement recommendations.
• Proven ability to lead cross-functional team meetings and collaborate across functions; strong interpersonal skills.
• Commitment to continual improvement, knowledge sharing, and fostering an inclusive culture.
• Ability to influence without authority; strategic thinker with creative problem-solving.
• Excellent teamwork, organizational, interpersonal, and problem-solving skills; effective cross-functional communication.
• Aptitude for data analytics and analytical thinking; attention to detail and critical thinking.
• Advocates diversity and inclusion and models these behaviors.
• Willingness to drive and support change and operate with ambiguity; decisive and capable of prioritization.

Location:

Massachusetts - Virtual. Base Salary Range: $ - $. The actual base salary offered depends on qualifications, experience, skills, education, certifications, and location. Benefits may include medical, dental, vision, 401(k) with company match, disability coverage, life insurance, tuition reimbursement, volunteer time off, holidays, well-being benefits, and paid time off. U.S. based employees may be eligible for incentives and various time-off policies, including sick time and paid vacation.

Takeda is an equal employment opportunity employer. It is unlawful in Massachusetts to require a lie detector test as a condition of employment. Takeda is committed to diversity and compliance with applicable laws. For applicants in the U.S. and Puerto Rico, follow the EEO information link for details. If accommodations are required to use the job application tool, please request them.