Manager, US Field Inventory Commercial Quality J&J Family of Companies - Raynham, MA Posted

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Quality

Customer/Commercial Quality

People Leader

Bridgewater, Massachusetts, United States of America, Mooresville, Indiana, United States of America, Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America

We are searching for the best talent for Manager, US Field Inventory Commercial Quality to join our DePuy Synthes Quality organization located in the United States.

This is a remote role available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

The Manager, US Field Inventory Commercial Quality is responsible for the oversight and execution of Quality and Compliance programs within the US Depuy Synthes Commercial Quality Region for last mile operations supporting loaner and field inventory activities. These facilities include Field Sales Network Locations (Orthopedic Last Mile Operations) which are managed by Depuy Synthes. This position provides oversight and guidance on quality & compliance related matters, partners with Commercial Operations and Deliver on orthopedic field inventory and loaner program related matters, liaises with Franchise Quality, Microbiological Quality and Sterility Assurance, and Commercial Quality partners to drive resolution of quality related issues.

• Where applicable, ensure Depuy Synthes Commercial Quality compliance to the Inter-Company Quality Agreement (ICQA) or legal contracts, including but not limited to:
  Audit and Inspection Management, Field Actions, Management Review, Purchasing Controls, Delivery Service Incidents, Product Quarantines, Holds, Recalls, Material and Product Controls.
• Where applicable, ensure compliance to the Quality Agreement (QAA), including but not limited to, Field Inventory standard, Inspection instructions, Regulatory Compliance, Change Control, Supplier monitoring, Quality Event Management, Non-Conformance, CAPA, Storage, Handling and Distribution, Product Returns and Disposal.
• Oversight of process and systems related with cGMPs, storage handling and distribution, quality investigations and managing partnerships with Franchises, 3PL and partners. Serve as single point of contact to internal and external partners on distribution quality related matters and liaise with other quality organizations to drive timely resolution of quality related issues.
• Create, review and approve assessment plans, risk assessment reports, non-conformance reports, corrective and preventive actions, audits, and other documentation.
• Support leadership and compliance activities including, but not limited to the creation and revisions of global and local procedures. Evaluate overall compliance risk, recommend corrective actions…