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.

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 for improvement.
• Demonstrated ability to effectively lead cross functional team meetings.
• Experience forming cross-functional collaborations; strong interpersonal skills.
• Supports a culture of continual improvement and innovation; promotes knowledge sharing.
• Ability to influence without authority.
• Thinks creatively; challenges the status quo.
• Thinks strategically, adopts breakthrough ideas.
• Encourages open dialogue.
• Takes decisive action and can prioritize.
• Proactively takes steps to learn and grow.
• Pragmatic and willing to drive and support change.
• Comfortable with ambiguity.
• Excellent teamwork, organizational, interpersonal, and problem-solving skills.
• Assertive and collaborative communication style.
• Aptitude for data analytics; analytical mind.
• Attention to detail and a critical thinker.
• Embraces and demonstrates a diversity and inclusion mindset and sets an example for these behaviors for the organization.
• Ability to effectively communicate cross functionally with people of various levels.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:
Massachusetts - Virtual

U.S. Base Salary Range:
$154,400.00 - $242,550.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

Locations
Massachusetts - Virtual

Worker Type
Employee

Worker Sub-Type
Regular

Time Type
Full time

Job Exempt
Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.