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Head of Manufacturing Business Systems

Takeda
Full-time
Remote friendly (Lexington, MA)
United States
$153,600 - $241,340 USD yearly
Operations

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Role Summary

Head of Manufacturing Business Systems responsible for providing strategic and tactical leadership to develop and drive the Manufacturing Digital Vision, owning manufacturing digital systems processes, and leading MES and Manufacturing Documentation Teams. Reports to the Head of Manufacturing.

Responsibilities

  • Shape the Manufacturing Digital Vision and lead the creation and execution of a comprehensive digital strategy for manufacturing to enable operational excellence, innovation, and future-readiness.
  • Serve as the Business Process Owner for all manufacturing digital systems, including current and future applications; oversee integration, optimization, and continuous improvement of these systems.
  • Provide leadership to the manufacturing documentation team, coordinating MES and paper document workflows and optimizing documentation processes for on-time project execution and compliance.
  • Manage a team of MBR designers to support MES implementations, upgrades, and BAU operations.
  • Lead or participate in shop floor/end-user workshops to develop user requirements for manufacturing systems.
  • Create user stories with acceptance criteria in collaboration with business representatives (manufacturing and quality).
  • Collaborate with MES SMEs to aid design, development, testing, and deployment of MES recipes; participate in design reviews and end-user testing.
  • Collaborate with Operations Technology, IT, and Science & Technology groups to influence long-term manufacturing strategies.
  • Support MES lifecycle activities (e.g., revision of batch records) as gatekeeper and releasing them for production use.

Qualifications

  • BS degree with 8+ years of experience, including 5+ years in MES, manufacturing process management, and/or documentation management
  • Knowledge of FDA validation requirements (preferred), including User Requirements, Design Specs, Business Process Procedures, and Design Reviews
  • Experience developing user requirements and functional specification documents
  • Proficiency with Microsoft products; TrackWise and Maximo experience a plus
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