Posted to MedZilla on 3/26/2017


Takeda Pharmaceuticals

US-MA, Associate Director Quality Assurance 1700721-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:

  • Develop and implement strategic approaches to batch review and disposition process for API, starting materials, excipients, bulk and finished drug product.
  • Manage Oral Solid Dosage (OSD) products from API through final packaging including the integration of Brigatinib and Ponatinib.
  • Manage staff and equitably distribute work to ensure timely review of batch documentation and disposition
  • Generate and/or review excursion reports to assess compliance of lots and disposition decisions
  • Provide direct oversight of all CMOs responsible for the manufacture of OSDs to ensure the quality and compliance of products
  • Team up with QA management to create and implement programs to nurture and provide career growth to junior members of the department

ACCOUNTABILITIES:

Monitor suppliers:
  • Lead off-site discussion and review of supplier performance and cGMP compliance.
  • Initiate, monitor and complete change controls related to Quality topics
  • Review and approve supplier documents requiring Quality approval
Support documentation and training efforts:
  • Initiate, revise and review controlled cGMP documents including SOPs, Material Specifications, investigation protocols and reports as applicable
  • Provide training on department-specific procedures and systems
  • Provide annual goals, learning plan(s), and development plan(s) for employee(s)
Help to monitor and improve Quality Systems:
  • Collect data, calculate, & report on departmental performance metrics
  • Identify and propose, lead Quality process and system improvements
  • Work with PCI to determine the root cause of missing capsules
Projects Teams:
  • QA representative to cross functional project teams such as tech transfer, etc
  • Participate on investigation teams and ensure proper close out and follow-up
  • Review and approve process, assay, and validation protocols and reports
  • Review and approve applicable sections of regulatory submissions
  • Prepare and review applicable sections of the Annual Product Review
Product Disposition:
  • Responsible for lot disposition decisions, assessment of excursions
  • Work with QPs to ensure continuous supply of product that meets ex-US markets
Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education:

  • A minimum of a bachelor s degree preferably in pharmaceutical sciences with 12+ years in a pharmaceutical/biotechnology industry with at least 10+ years in Quality Assurance
Behavioral Competencies and Skills:
  • 6+ years of leadership and management experience in Quality functions
  • Extensive knowledge in cGxPs, ICH and other pharmaceutical regulations
  • Ability to interact effectively with senior management across departments
  • Ability to thoughtfully analyze information and data to make key decisions regarding potential risks associated with product quality or regulatory violations
  • Ability to establish professional relationships and rapport with internal and external teams and upper management
  • Ability to detect potential problems and risks related to commercial product operations, investigate, and implement solutions in a timely manner
  • Contract Manufacturing Organizations management experience
  • Excellent organization, writing, communication and presentation skills

PHYSICAL DEMANDS:

  • Routine demands of an office based environment
TRAVEL REQUIREMENTS:
  • ~30%



we are driven to improve people's lives

www.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, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.


Schedule
Full-time


Please visit our website at takedajobs.com

 
 


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