Posted to MedZilla on 4/24/2017


Takeda Pharmaceuticals

US-MA, Associate Director, Quality Control 1700049-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:

Responsible for the management of Release and Stability activities, data review, tracking and trending, authoring of stability protocols and reports, support regulatory submissions activities, manage service providers and coordinate study executions for all late phase and/or commercial products managed by the Commercial Quality Organization.

ACCOUNTABILITIES:

Core Responsibilities
  • Oversee service providers in accordance with quality agreements
  • Set timelines for testing and study execution
  • Manage data review for all products managed by the Release/Stability Team
  • Develop and/or refine the testing and data review programs to increase efficiency
  • Review release/stability data and generate COA s
  • Serves as Commercial Quality Control representative to cross functional project teams

Data Management
  • Identify and resolve testing issues with service providers
  • Ensure data is reviewed in a timely manner for release, stability and/or regulatory submissions
  • Trend Release and Stability data (graphical analysis) and Statistical Analysis where applicable
  • Ensure all applicable excursions, change controls are properly documented and closed on time

Contract laboratory management
  • Primary contact with Contract Testing service providers
  • Coordinate delivery of all GMP testing documentation
  • Monitor Release and Stability testing and documentation
  • Ensure service providers methods/Material Specs are consistent with MPI/Takeda documents
  • Present metrics/review major projects and address issues with vendors
  • Support the new initiatives and process improvements
Technical Writing
  • Author and present Change Controls as needed
  • Author OOS, Atypical Investigations as needed
  • Author, revise, review SOPs, Stability protocols and reports
  • Author Annual Product Quality Review Testing sections for all products managed by the Commercial Quality Group
  • Review/Verify stability and batch analysis sections for regulatory submissions
People Management
  • Manages direct reports
  • Determines strategies and goals for team members, learning plan(s), and development plan(s) for employee(s)

Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelors or Master s Degree in any Life Sciences, minimum 10+ years of biopharmaceutical experience
  • Previous industry experience in a regulated environment highly desirable
  • Minimum 7 years of direct managerial experience
  • Knowledge of cGMP regulations for US, Japan, EU and other markets
  • Effective time management, teamwork and collaboration
  • Strong verbal and written communication (including presentation) and customer management skills
  • Demonstrated ability to effectively organize and execute tasks
  • Demonstrates proficiency in negotiation and conflict resolution
  • Computer proficiency

PHYSICAL DEMANDS:

  • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
TRAVEL REQUIREMENTS:
  • 10% potential domestic or international 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.


Schedule
Full-time

Please visit our website at takedajobs.com

 
 


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