Senior Manager, Quality Assurance
Location:
Boston , Massachusetts
Posted:
October 21, 2017
Reference:
1701977


Are you looking for a patient-focused, innovation-driven 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 Senior Quality Assurance Manager in our Cambridge, MA office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Quality Assurance Manager within Global Quality, you will be empowered to manage all oral solid dosage products from API through final packaging including the management of CMOs. A typical day will include:

POSITION OBJECTIVES:
  • Managing all Oral Solid Dosage products from API through final packaging including the integration of new products.
  • Develop and implement strategic risk based lean approaches to the batch review and disposition process.
  • Developing and implementing strategic risk based lean approaches to the batch review and disposition process.
  • Serve as QA representative to cross functional project teams such as tech transfer, computer systems, process improvement, etc.


POSITION ACCOUNTABILITIES:


  • Participating in issue detection and resolution with API manufacturers.
  • Being accountable for the commercial API lot review and release process.
  • Monitor suppliers and lead off-site visits and teleconferences for discussion and review of supplier performance to established schedules and cGMP compliance.
  • Initiate, monitor and complete change controls related to Quality topics.
  • Partner with CMO’s to develop and monitor applicable quality metrics.
  • Identifies and facilitates continuous improvement efforts to improve CMO batch release metrics as needed.
  • Participate in CMO JOC’s (Joint Operating Committee meetings) as requested.
  • Provide annual goals, learning plan(s), and development plan(s) for employee(s), including training and development.
  • Help to monitor and improve Quality Systems through data collection, calculation, and reporting on departmental performance metrics.
  • Identify and propose Quality process and system improvements by leading improvement projects.
  • Initiate, revise and review controlled cGMP documents including SOPs, Material Specifications, and investigation protocols and reports as applicable.
  • Identifies and facilitates continuous improvement efforts to improve CMO batch release metrics as needed.
  • Participate on investigation teams and ensure proper close out and follow-up.
  • Review and approve process, assay, and other validation protocols and reports as applicable.
  • Prepare and review applicable sections of regulatory submissions and applicable sections of the Annual Product Review.






Qualifications:



EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
  • Bachelor’s degree preferably in pharmaceutical sciences with 10+ years in a pharmaceutical/biotechnology industry with at least 7 + years in Quality Assurance and/or Compliance.
  • 5 + years of leadership and management experience in Quality functions.
  • Extensive knowledge in cGxPs, ICH and other pharmaceutical regulations.
  • Prior experience working for a Contract Manufacturing Organization.

TRAVEL REQUIREMENTS:
  • Ability to travel 20% to Takeda and CMO sites.



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.


A little about us:
Takeda fosters an inclusive environment where all employees are empowered to shine.

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