Director, Quality Architecture
Location:
Cambridge , Massachusetts
Posted:
February 15, 2017
Reference:
1602275
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. As a global, research and development-driven pharmaceutical company, Takeda Pharmaceutical Company Limited conducts R&D both internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology and central nervous system, plus vaccines. 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:
  • Provides R&D leadership and strategic direction for R&D Quality Systems.  This role partners with the Global Quality function and R&D.
  • Drives Quality activities to support the business as well as monitor the business, working closely with the Head of Global Quality Programs.
  • Provides regulatory and technical expertise and supports the development of the R&D Quality Management System, ensuring alignment of R&D Quality Management Systems with Global Quality organizing principles and the R&D business.
  • Supervises the global Quality professionals (approximately 5-7 people) responsible for R&D Quality Systems.
  • Participates as a key member of the R&D Quality Systems and Compliance Management Team.
  • Acts as the Change Management process owner.
ACCOUNTABILITIES:

  • Provides R&D leadership and strategic direction for R&D Quality Systems.
    • As both Global Quality and R&D refine the business of Quality and the R&D long range plan, closely align the following processes: risk management (both Quality and PV), change management, deviations, investigations, and CAPA.
  • Drives Quality execution activities to support the business for deviations, investigations and CAPA
    • Plays a support role for significant R&D inspection activity.
  • Provides regulatory and technical expertise and leads the development of the R&D Quality Management System, ensuring alignment of R&D Quality Management System with Global Quality organizing principles and the R&D business.
    • Ensures the R&D Quality Management System is aligned with Global Quality and are in a state of compliance.
    • Interprets new regulations and incorporates as appropriate in the R&D Quality Management System.
  • Supervises the global Quality professionals (approximately 5-7 people) responsible for R&D Quality Systems.
  • Provides Quality System Support including the development and management of documentation (standards, sops) and training.
    • Provides global regulatory expertise for existing and emerging R&D GXP regulations and incorporates as appropriate in the R&D Quality Management System.
    • Oversees the risk management process.
    • Oversees the change management process.
    • Oversees the execution of investigation and deviation management.
  • Participates as a key member of the R&D Quality Systems and Compliance Management Team


Qualifications EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelor's Degree in Chemistry, Biology, Engineering or related field.  Masters preferred.
  • Minimum of 10 years of increasing responsibility and experience in the global pharmaceutical industry.
  • Minimum of 7 years of Quality/QC/Compliance experience, with at least 4 years experience in developing and managing global Quality Systems.
  • In-depth understanding of global regulations governing the US and international pharmaceutical industries.  Ability to translate and articulate appropriate strategies and activities to ensure compliance to all regulations relative to quality management systems.
  • At least 5+ years of managerial experience including senior level project planning.
  • Experience working within a complex organization and demonstrated ability to work across functions and regions, at all levels where the incumbent may not have direct authority.
  • Expert knowledge and experience with risk management strategies, project reporting, and general project management experience/expertise required. Proven track record in managing global teams.  Experience leading and managing complex and matrix teams and processes in a global organization.  Proven success in identifying and implementing organization-wide compliance initiatives.
  • Ability to interpret regulatory intelligence and translate, as appropriate, into R&D's Quality System.
  • Experience in working with/managing with regulatory agency relationships relative to all GMP quality systems issues.
  • Ability to influence and work effectively with various business partnerships, regions and cultures.
  • Strong interpersonal skills particularly motivational, negotiation, listening, judgment, and conflict management skills, demonstrated by ability to lead teams in a complex, matrixed and global environment.
  • Excellent organization, verbal and written communication skills to explain project goals and inspire support.
  • Ability to work well with cross-functional teams to accomplish objectives.  Ability to work effectively in a fast paced, rapidly changing technology environment, and to work on multiple work streams and projects simultaneously.
  • Demonstrated analytical capabilities with the ability to analyze a wide variety of information and data to make management decisions regarding potential risks associated with regulatory compliance.
  • Demonstrated proficiency in MS Office applications required; proficiency in Quality Systems Databases such as Track Wise highly desirable.
  • Demonstrated ability to anticipate potential problems and risks related to quality system expectations and regulatory compliance, formulate action plans, and implement solutions
  • Must have an advanced knowledge and understanding of the drug development process, scientific methods and thought processes, specifically the manufacturing process, to ensure regulatory compliance information is up-to-date.


TRAVEL REQUIREMENTS:

  • Travel required, approximately 15-20%, domestic and international.

*LI-JW1-USA


we are driven to improve people's lives

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

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Schedule
Full-time

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