Posted to MedZilla HealthCare on 7/20/2018

Takeda Pharmaceuticals

US-MA, Sr. Manager, Quality Systems, Global Product Change Control R0001264-MZ


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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Sr. Manager, Quality Systems, Global Product Change Control in our Cambridge, MA office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. Sr. Manager, Quality Systems, Global Product Change Control in working on the Oncology & Biologics Quality team, you will be empowered to create and implement programs and strategies focused on CMC change control and set the strategic compliance direction for critical system processes. A typical day will include:


  • Responsible for creating and implementing programs and strategies for quality management systems, focusing on CMC change control and processes such as APR/PQR that support GDPs operations for the Oncology & Biologics Quality organization and its applicable alliance partners and suppliers
  • Serve as Takeda Boston site quality representative, setting strategic compliance direction for critical quality management system processes, including validation, global product CMC change control, and data integrity
  • Provide and ensure training delivery for the Oncology & Biologics Quality organization associated to relevant quality systems such as validation, change control and data integrity
  • Manage quality system workflows in applicable systems, ensuring Oncology & Biologics global products remain compliant
  • Assure compliance with product change control procedures for products, assist global product launch teams to ensure CMC changes have been filed and authorized by applicable management and global personnel and have received appropriate regulatory approvals prior to product distribution
  • Serve as subject matter expert regarding regulatory requirements, assuring compliance with all Global Takeda quality system standards and procedures for Oncology & Biologics products with a focus on those impacting product change control
  • Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies related to quality systems, and support
  • Represent the Quality Systems functional area as a subject matter expert (SME) during regulatory and third-party inspections

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