at Takeda Pharmaceuticals in Montpelier, Vermont, United States
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.
Clinical Quality Management (CQM) at Takeda
Clinical 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.
OBJECTIVE S :
This position reports to a Director of RBQM Operations and is responsible for successfully implementing and coordinating RBQM procedures at the study level, including initial and recurring risk identification, assessment, centralized risk monitoring, and mitigation activities within the RBQM framework.
+ Responsible for theimplementation of RBQMprocedures for assigned studies
+ Reviews study protocoland facilitates development of the Study Risk Assessment that definescritical data, critical processes, andmeaningful key risk indicators including quality tolerance limits in collaboration with the study team
+ Develops study specific content and leads RBQM training and RBQM kick-off meetings
+ Authors and implements the study specific RBQM plan
+ Leads risk assessment meetings, engaging cross-functional study team members to identify Critical-to-Quality (CtQ) risks throughout the trial lifecycle
+ Partners with the RBQM system configuration team to ensure risk indicators, quality tolerance limits and otheranalytics/visualizations are programmed and functioning per operational requirements in the RBQM system
+ Performsperiodic central monitoring of the aggregate data at the study, region, country, site, and patient levelsleveraging availableanalytics/visualizations in the RBQM systemto 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
+ Createssignal 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 ofother (junior) staff within RBQM Operations
EDUCATION, EXPERIENCE , KNOWLEDGE, AND SKILLS:
Education: Bachelor’s Degree in a health-related, life science area or international equivalent preferred, or equivalent combination of education, training, and work 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)
+ Requires0- 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."
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
North Carolina – Virtual