at Takeda Pharmaceuticals in Montpelier, Vermont, United States
Job Description
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Job Description
OBJECTIVES/PURPOSE
+ Lead/drive development and implementation of compliance management for clinical trial delivery including quality event determination and documentation, liaising with QA and managing & closing CAPAs; Report non-compliance as needed
+ Etablish and lead proactive compliance framework for clinical trial delivery functions; establish key performance indicators for clinical trial delivery, leadership reporting and mitigation strategies.
+ Develop, lead and drive clinical trial delivery metrics and reporting including but not limited to training and CAPA completion compliance
ACCOUNTABILITIES
+ Lead compliance management clinical trial delivery including deviation determination, documentation, liaising with QA and managing & closing CAPAs; Report non-compliance as needed
+ Establish and lead proactive compliance framework for clinical trial delivery functions; establish key performance indicators for clinical trial delivery, leadership reporting and mitigation strategies.
+ Manage compliance reporting for clinical trial delivery and facilitate leadership review; work with functional areas to solve compliance gaps
+ Support study execution teams on compliance to clinical trial delivery SOPs; manage and report non-compliance
+ Identify and highlight risks and issues within project(s) and escalate appropriately.
+ Identify, develop, and implement effective mitigation and escalation strategies for projects to address risks and issues
+ Liaise with QA to ensure compliance to Quality Plan
+ Active participation in quality forums within Takeda and external industry groups
Other
+ Responsible for training, coaching and mentoring supervised employees (direct and indirect reports) to create a culture that attracts, retains and develops innovative thinkers
+ Act as role model for Takeda’s values
EEO Statement
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.
Locations
Massachusetts – Virtual
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
\#LI-Remote
