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Team Lead - CMC Systems Oversight

応募 後で応募 求人ID R0015571 掲載日 01/09/2020 Location:Lexington, Massachusetts; Boston, Massachusetts

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Job Description

Job Description – Associate Director, Systems Oversight

  • Demonstrates a high level of leadership and understanding of GRA-CMC roles, capabilities, and applicable CMC and GXP requirements relevant to the development and maintenance of systems and processes related to
    • Change management
    • Regulatory submissions
    • Post-marketing commitments
    • Clinical and commercial supply
  • Represents GRA-CMC on cross-functional teams developing and maintaining Quality, Supply and regulatory systems
  • Manages, develops and mentors staff members responsible for GRA-CMC change management procedures
  • Proactively recognizes and contributes to enhancing business processes
  • Responsible for adapting, developing or maintaining GRA-CMC procedures in accordance with Global, GRA, and PharmSci and GMS/GQ policies and standards
  • Responsible for developing and communicating meaningful metrics for post-approval submissions to facilitate resourcing decisions and planning
  • Responsible for supporting post-approval submissions and projects as an individual contributor where needed
  • Exercises good judgement in elevating and communicating actual or potential issues to line management
  • Ensures that stakeholders are kept aware of developments around systems and processes that have the potential to impact GRA-CMC resources and priorities

Education, Behavioral Competencies and Skills

  • Demonstrates Takeda’s leadership behaviors
  • Understanding of change control, regulatory submission requirements
  • Flexible, pragmatic, good communicator
  • Demonstrates ability to think strategically on systems issues, anticipate potential roadblocks and to collaborate with stakeholders to solve problems
  • Experience leading a team preferred

Locations

Lexington, MA

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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