Takeda fosters a collaborative and stimulating work environment, filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; gastroenterology, oncology, neuroscience, plasma-derived therapies, rare diseases and vaccines. Boston (Massachusetts) is the R&D (Research & Development) headquarters.

ACCOUNTABILITIES:

• Responsible for the implementation of RBQM procedures for assigned studies

• Review study protocol and facilitates development of the Study Risk Assessment that defines critical data, critical processes, and meaningful key risk indicators including quality tolerance limits in collaboration with the study team

• Develop study specific content and leads RBQM training and RBQM kick-off meetings

• Author and implement the study specific RBQM plan

• Lead risk assessment meetings, engaging cross-functional study team members to identify Critical-to-Quality (CtQ) risks throughout the trial lifecycle

• Partner with the RBQM system configuration team to ensure risk indicators, quality tolerance limits and other analytics/visualizations are programmed and functioning per operational requirements in the RBQM system

• Perform periodic central monitoring of the aggregate data at the study, region, country, site, and patient levels leveraging available analytics/visualizations in the RBQM system to identify emerging risks and/or issues

• Leads risk review meetings and discussions with study team members to effectively communicate and discuss the findings, facilitates and encourages robust root cause identification and mitigation strategies

• Ensures corrective actions and preventative actions are properly documented, assigned, and implemented by assigned study team members and/or impacted functions

• Monitors the effectiveness of study risk mitigation actions in reducing the risk signals; makes recommendations to adjust as needed

• Creates signal and trending reports for study teams to support their interpretation of RBQM output

• Partners with the Adaptive Monitoring Excellence team for signals requiring review or adjustment to study level plans for targeted source data verification and source data review

• Maintains up-to-date, accurate documentation of RBQM activities

• Supports and participates in internal and external audits and inspections

• Maintains high quality, consistency, and compliance with RBQM procedures across studies

• Adjusts RBQM plan appropriately based on both anecdotal feedback and data-driven trends in overall RBQM success measures

• 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

Experience:

• Minimum of 6 years of experience in the pharmaceutical or CRO industry

• Minimum of 2 years of experience in Risk Based Quality Management

• Minimum of 2 years of 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)

TRAVEL REQUIREMENTS:

• Requires 0 - 10 % travel, potentially including overnight and international travel

Base Salary Range: $130,200 Range Min to $186,000 Range Mid. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

“This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.”