A | MOST OFTEN, THE GMP/GDP COMPLIANCE FUNCTION reports into the affection operations (assurance) alignment (supporting accomplishment and supply). Within this alignment the academic acquiescence roles can be centralized in a amount assemblage or decentralized beyond departments. However, it is not aberrant for acquiescence action and blank to be alien to operations and address anon to the acquiescence officer. This anatomy lends itself to greater afterimage into an action acquiescence archetypal but presents shortcomings if bright cross-functional partnerships are not established. The acquiescence alignment should analyze risks, admonish on the architecture and accomplishing of mitigations and controls, and be complex in establishing capability measures — all while arena a cogent role in artefact affection and abiding business continuity.
JASON URBAN, PH.D. is the arch of Celgene’s Business Operational Excellence function.
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