Job Title: Quality Manager (Logistics)

Duration: ~7 months (potential extension)

Location: Lexington, MA 02421

Purpose:

• The role is responsible for quality support of US Domestic Distribution Logistics (USDDL), which includes the US and Puerto Rico.
• This includes quality support for the Patient Assistance Program (PAP), Access to Medicines (ATM), and the Physician Sample Program in the US.
• The role is also responsible for Quality support of US Global Distribution Logistics (USGDL) in regards to exports from the US to other markets.
• The role is also responsible for Quality support of the US Customer Experience.

Primary Duties/Responsibilities:

• Support US Commercial Quality in support of USDDL.
• Perform the following activities in support: temperature evaluations, identify and initiate deviations, manage product returns, quality approver for change controls and CAPAs, and other applicable compliance activities related to our regional distribution centers (RDC)/3PL’s.
• Support US Commercial Quality in support of USGDL.
• Support quality approval for investigations related to exports from the US to other markets.
• Review and approve USGDL procedures and transport validation documents.
• Train and become proficient in enterprise systems: TrackWise, SAP (inventory), and Veeva.
• Train and become knowledgeable of the requirements related to the Drug Supply Chain Security Act (DSCSA)/serialization, controlled substances (Orders of Interest), and anti-diversion/counterfeit.
• Support the management of US-approved suppliers, including 3PLs, 4PLs, transportation carriers, etc.
• Management includes participating in quality business reviews, managing quality agreements, audits, and supplier records in the Supplier Management System.
• Execute standards and procedures related to risk management, self-inspection, internal audits, Quality Council, Supplier Business Reviews, and other applicable quality system elements.