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A strategic role that drives enhanced compliance throughout the PV domain to support the obligation of the Marketing Authorization Holders and appointed QPPV, to maintain and improve a Global PV system in accordance with international regulations.
Provide expert advice on GVP compliance and regulatory matters, acting as quality partner to PV Operations (US/DK) and the EU QPPV. Author and maintain GVP Quality procedures and support implementation of new or updated GVP requirements.
Ensuring that all the activities performed are maintained in compliance with applicable regulations, that appropriate authorizations/licenses and certificates are in place and current and that the integrity and safety of product are maintained throughout
Provides guidance and oversight to internal and external project team members for the successful management of clinical operation activities in accordance with International Council on Harmonisation of Technical Requirements for Registration of