Posted to MedZilla on 4/25/2017

Takeda Pharmaceuticals

US-NC, Senior Manager, Quality Control - Vaccine Business Unit 1700428-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!


  • Evaluate, develop, implement, and manage processes to support the VBD (Vaccine Business Division) GMP Quality Control (QC) organization. This role partners with global colleagues to provide leadership and ensure there is a compliant, efficient and scalable processes throughout the VBD organization.
  • Manage in-process, release and stability testing of multiple vaccine programs on the global scale. Manage contract testing and manufacturing relationships. Lead investigations and method transfer activities.
  • Develop strategic direction for the quality control group to ensure a state of compliance and agreement with regulatory requirements and Corporate and Division Quality Standards and expectations.


  • Lead global teams including QC technology transfer teams
  • Orchestrate QC release and stability testing of GMP drug substances and drug product materials associated with global R&D and commercial programs, including development and implementation of stability programs and collaborative interactions with CMO/CTOs for scheduling and performance of testing
  • Review and analyze GMP test results, prepare interim and final testing reports, develop investigation protocols and reports, prepare summaries and other documents for communication with regulatory agencies. Present findings both internally and externally, including regulatory agencies.
  • Lead test result investigations and test method optimizations, manage GMP test method life cycle, and design strategic plan for process and product development.
  • Assess method and program for compliance with GMP requirements, guidance documents, and determine critical quality attributes. Implement strategies for adding new GMP test methods and verify suitability for company materials.
  • Survey global regulatory guidance and trends (e.g. ICH Q2R1), perform gap analyses relative to VBD current state, and formulate/implement improvement initiatives.
  • Additional duties as assigned.



  • Bachelor s Degree in Chemistry, Biology, Engineering or related field.


  • Minimum 10 years experience in Quality or Regulatory compliance (FDA, EMA or other) within the pharmaceutical, biologics or vaccine industry, with specific focus on developing and managing global GMP Quality Systems.
  • Minimum 7 years experience in GMP QA and/or QC
  • Experience leading and managing complex and matrix project teams and processes in a virtual organization (e.g. change control, CAPA, deviations, product complaints, management review)
  • Direct experience developing and assessing metrics and data, analyzing for trends, and reporting to global, senior-level management on GMP State of Compliance (Management Review).

Behavioral Competencies and Skills:

  • Regulatory Knowledge in-depth understanding of global regulations governing the US and international pharmaceutical industries
  • Proven leadership, team building skills and strategic problem-solving ability. Ability to manage and lead others through change. Demonstrated ability at managing matrix teams, influencing outcomes and key project decisions
  • Proven ability to communicate and collaborate effectively with senior management. Experience interacting with external collaborators with ability to build strong relationships.
  • Knowledge of risk management, project reporting, and general project management experience/expertise required.
  • 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 TrackWise or similar systems highly desirable.
  • Proactiveness ability to anticipate potential problems and risks related to quality system expectations and regulatory compliance, formulate action plans, and implement solutions
  • Must have a fundamental understanding of the drug development process, scientific
  • methods and thought processes.


  • Routine demands of an office based environment.
  • Requires approximately 20% travel, both domestic and international.

we are driven to improve people's lives

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, visit

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