The Preclinical Compliance Team is responsible for the development, maintenance and execution of compliance strategies and programs for non-GXP and GXP Discovery and Preclinical
development work within DPDS (Discovery, Product Development and Supply). This requires enabling fit for purpose processes and tools and facilitating the right organizational culture, through close collaboration with functions and stakeholders, in order to ensure reconstructable and trustworthy data that support internal decisions and external scrutiny.
The Preclinical Compliance Team manages 5 Compliance programs:
(1) Compliance Strategy
(2) Onboarding, Training and Knowledge management
(3) Procedures, Tools, and documents
(4) Data and materials transfer and archiving
(5) Compliance status.
The team is also responsible for managing GXP inspection readiness programs and inspection support as well as tactical and operational compliance support for the Preclinical Sciences and Translational Safety (PSTS) organization. The team is also responsible for Controlled Substances Compliance oversight for DPDS.
The primary focus of this temporary assignment is on Compliance program (2) Onboarding, Training and Knowledge management; however, support may be given to other areas considering business priorities.
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