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,
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
- Track/Trend relevant data and identify,
evaluate and develop corrective actions and responsible for driving gap
- 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
- 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
- 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
- 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
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
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