Job Description:
Primary Duties/Responsibilities:
Qualifications:
- The role is responsible for quality support of US Domestic Distribution Logistics (USDDL) which includes US and Puerto Rico.
- This includes quality support for Patient Assistance Program (PAP), Access to Medicines (ATM), and 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 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 Takeda’s enterprise systems: TrackWise, SAP (inventory), and Veeva. Train and become knowledgeable of the requirements related to Drug Supply Chain Security Act (DSCSA)/serialization, controlled substances (Orders of Interest), and anti-diversion/counterfeit.
- Support the management of US Approved Suppliers including 3PL’s, 4PL’s, transportation carriers, etc. Management includes participating in quality business reviews, managing quality agreements, audits, and supplier records in the Supplier Management System.
- Execute Takeda standards and procedures related to risk management, self-inspection, internal audits, Quality Council, Supplier Business Reviews and other applicable quality system elements.
Qualifications:
- Bachelor’s degree (or equivalent experience) and 5+ years of experience in Quality, preferably in the pharmaceutical industry.
- Well versed in quality activities such as supplier quality, deviations, change controls, audits, CAPAs, etc.
- Experience with enterprise systems such as TrackWise, SAP (inventory), and Veeva a plus.