Associate Director, Global Clinical Distribution Quality

Job Description

General Summary:

The Associate Director, Global Clinical Distribution Quality role will work with the GMP Operational QA team to ensure that medicines are distributed in compliance with GDP and GMP requirements for Clinical Distribution.

Key Duties and Responsibilities:

• Lead Clinical Quality Distribution team to support the Clinical Supply Chain activities, providing expert GDP support for clinical execution, pharmacy manual standards, ISR (investigator sponsored research) and home-dosing programs where necessary.
• Support the on-time completion of commitments for clinical supply including risk management, change control implementation, deviation/investigation review, and CAPA completion.
• Point of escalation for clinical site queries regarding handling and use of investigational product as it pertains to GDP
• Point of escalation for interactive response technology (IRT) issues related...

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