Associate Director, Clinical Quality Operations
The Judge Group Inc.

Gaithersburg, Maryland


Location: Gaithersburg, MD
Description: Our client is currently seeking a Associate Director, Clinical Quality Operations

This job will have the following responsibilities:

Quality leader to set and execute QA Operations strategy with Development, Manufacturing, Quality Control, Supply Chain, and Clinical Operations to ensure product is developed, manufactured, tested, labeled, and shipped to meet domestic and international regulations including FDA and EU GxPs.

•This includes interface with internal and external Qualified Persons (QPs), internal company supply nodes and subcontractors for testing and fill/finish.

•Supporting global quality operational strategies by establishing critical quality and operational metrics and measurements and conducting trend analysis for GxP CMO activities.

•Provides mentorship, leadership, and prioritization to staff to execute their respective duties

•Builds and promotes a culture of Operational Excellence within QA.

•Stays current and is an internal company subject matter expert for changes in GxP expectations, including FDA, EU and other relevant foreign regulatory bodies, guidance documents (i.e.: ICH, PTC, ISPE, etc.), and best industry practices.
Qualifications & Requirements:

Bachelor's Degree in with 10+ years' industry experience.

•2+ years' people management experience.

•Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development through commercial application, including technology transfer and PPQ.

•Stays current with changes to current GMP/GCP regulations including FDA and EU.

Contact: arawat@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com


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