Senior Manager Quality Assurance - Biologics
Location:
Cambridge , Massachusetts
Posted:
October 21, 2017
Reference:
1701631


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 Senior Manager, Manufacturing Quality Assurance in our Cambridge, MA office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Manager, Manufacturing Quality Assurance working on the Quality Team, you will be empowered to represent Takeda on cross-functional project teams and ensure our quality culture is maintained. A typical day will include:

POSITION OBJECTIVES:

  • This role is a part of ensuring Takeda’s mission is achieved through quality standards and procedures.


POSITION ACCOUNTABILITIES:

  • Commercial Quality Assurance manager primarily responsible for Quality oversight at assigned Pharmaceutical Vendor(s).
  • Provide QA Management assessment of all manufacturing and testing excursions at assigned Pharmaceutical Vendor(s).
  • Serve as QA representative on cross-functional project teams such as tech transfer, validation, computer systems, process improvements, and investigations.
  • Provide support and coaching for QA Specialists.
  • Support other QA related functions as needed such as authoring and/or reviewing dossiers, investigations, risk assessment reports and onsite presence during manufacturing etc.
  • Perform product release activities and CMO site management.




Qualifications:



EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:


  • A minimum of a bachelor’s degree preferably in pharmaceutical sciences with 10+ years in a pharmaceutical/biotechnology industry with 5+ years in Quality Years of experience.
  • Cell culture experience.
  • Drug substance / Drug Product Quality manufacturing experience.
  • Quality documentation experience, Batch records, SOPs, Quality agreements, etc.
  • Desire to put people first and demonstrate the values of Takeda-ism.



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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