Posted to MedZilla on 12/13/2018

Takeda Pharmaceuticals

US-MA, Quality Assurance Technical Manager II - Biologics R0005060-MZ


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Job Description


  • Perform quality technical support for commercial drug substance, drug product, finished goods
  • Perform the role of lead Quality liaison for technical support with CMOs


  • Provide technical investigation support in review of deviations and investigations to assess cGMP compliance of lots
  • Lead off-site visits and teleconferences for discussion and review of supplier performance and cGMP compliance
  • Provide person in plant assistance as necessary
  • Review/Approve technical change controls as they relate to drug substance, drug product and finished goods
  • Review/approve controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, Process Validation protocols/reports as applicable
  • Identify and propose Quality process and system improvements. Lead improvement projects
  • Serve as QA representative to cross functional project teams such as tech transfer, process validation, and process improvements
  • Review and approve process, assay, and other validation protocols and reports as applicable
  • Review and approve applicable sections of regulatory submissions
  • Provide Global Quality Auditing SME support as necessary
  • Provide support in the evaluation/implementation new technologies
  • Support QA review and disposition of validation/commercial lots of drug substance, drug product, finished goods


  • BA/BS (or Master's) in any Life Science discipline preferred, and/or 10+ years experience
  • Understands and applies good working knowledge of quality and GMP principles.
  • Ability to handle multiple tasks concurrently and in a timely fashion.
  • Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
  • Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management.
  • Must display eagerness to learn and continuously improve.
  • Positive work attitude that supports teamwork and continuous improvement.
  • Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
  • Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.
  • OSD, Parenteral and/or Biologic manufacturing knowledge is preferred.


  • Wrist and hand motion (e.g. typing, writing)
  • Must be able to work in controlled or clean room environments requiring special gowning


  • Willingness to travel to various meetings or client sites, including overnight trips
  • Requires approximately 25% travel

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Cambridge, MA

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Time Type

Full time

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