Posted to MedZilla on 3/29/2017


Takeda Pharmaceuticals

US-MA, Quality Assurance Manager I 1700109-MZ


 
 

More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients lives. If you are driven to create better health and a brighter future, join us!

OBJECTIVES:

  • To perform lot review/release activities for commercial drug substance, drug product, and finished goods
  • To perform the role of lead Quality contact for CMOs

ACCOUNTABILITIES:

This position is focused primarily on providing support and guidance on non-complex and routine quality-related issues.

This individual:
  • Provide QA review and disposition of commercial lots of drug substance, drug product and finished goods
  • Distribute work to QA staff to assure timely review of batch documentation
  • Generate and/or review deviations and investigations to assess cGMP compliance of lots
  • 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 topcs
  • Review and approve supplier documents requiring Quality approval
  • Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, Process Validation protocols/reports as applicable
  • Provide training on department specific procedures and systems
  • Collect data, calculate, and report on departmental performance metrics
  • 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
  • Lead 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
  • Prepare and review applicable sections of the Annual Product Reviews
Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • BA/BS (or Master's) in any Life Science discipline preferred, and/or 8+ 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.

PHYSICAL DEMANDS:

  • Wrist and hand motion (e.g. typing, writing)
  • Must be able to work in controlled or clean room environments requiring special gowning
TRAVEL REQUIREMENTS:
  • Willingness to travel to various meetings or client sites, including overnight trips
  • Requires approximately 25% travel



we are driven to improve people's lives

www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

*LI-CB1-USA


Schedule
Full-timeQualifications

Please visit our website at takedajobs.com

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.