Posted to MedZilla on 11/20/2017

Takeda Pharmaceuticals

US-MA, Manager, Quality Documentation Training 1703003-MZ


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 Manager, Quality Documentation & Training in our Cambridge, MA office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager, Quality Documentation & Training working on the Quality team, you will be empowered to manage and execute the business performance and execution of the Quality Documentation and Training group. A typical day will include:


  • The Manager, Quality Documentation & Training contributes to Takeda s mission through the management of compliance, business performance and execution of Takeda Boston (TBOS) Oncology & Biologics Quality Documentation & Training group Quality File rooms (QFRs) and archiving program and processes.
  • Manage the Principal Archivist (PA) Program and cross-functional Team.
  • Manage GxP Documentation LEADs system and processes to include workflows, periodic reviews and Training for specific LOC customer base.
  • Maintain inspection readiness for Takeda Boston (TBOS) Documentation, Training and Archiving for Oncology & Biologics Quality and Operations, Takeda Boston (TBOS) Facilities and TBOS GMA.


  • Manage compliance for Quality File Room(s) (QFRs) processes that include Archive/Record Management, Control of Master Archival indices, Vital Record Management, Disaster Recovery preparedness, off site archival and Record Retention.
  • Manage BRM (Business Record Management) compliance for O & B TBOS Quality per Legal Department guidelines.
  • Ensure efficient and compliant operational Documentation & Training programs, monitor progress, identify inefficiencies and implement corrective actions per procedures.
  • Manage and monitor LEADs system and process compliance including collaborating with and driving Global Quality initiatives.
  • Track/Trend relevant data and identify, evaluate and develop corrective actions and responsible for driving gap closure.
  • Fill role as subject matter expert in origination and Quality Review of Documentation, Training and Archive management Procedures, Deviations, CAPAs and Investigations.
  • Support audits/inspections and serve as Senior Delegate/Delegate to the Principal Archivist (duties described below).
  • Manage PA Program by identifying continuous improvement opportunities; implement and revise procedures and processes as appropriate.
  • Manage Archive Indices in a validated environment.
  • Consistently collaborate and drive assigned target completion with initiatives and deliverables for Global Quality, Oncology O&B TPUSA Documentation and Training and Brooklyn Park.


  • Bachelor of Science and 8 years experience, 3 years in Pharmaceutical and/or Quality Environment
  • Experience with people management and development, documentation, archiving/record management systems/processes
  • Ability to manage projects with strong team and collaboration skills
  • Must have strong knowledge and experience implementing and managing documentation, training and archiving systems and processes
  • Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs
Empowering Our People to Shine
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Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit

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