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:

POSITION OBJECTIVES:

  • 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.

POSITION ACCOUNTABILITIES:

  • 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.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • 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
TRAVEL REQUIREMENTS:
  • Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
WHAT TAKEDA CAN OFFER YOU:
  • 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
Learn more at takedajobs.com.

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 http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.


Schedule
Full-time


Please visit our website at takedajobs.com

 
 


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