Global Lead of Content and Document Management

RocheMississauga, ON
Remote

About The Position

The Global Lead, Engineering Content & Document Management is responsible for the strategic design, implementation, and governance of the information management framework within the Global Engineering function. This role ensures that all technical documentation and engineering content—integral to the design, construction, and qualification of pharmaceutical manufacturing assets—are managed according to international best practices and stringent regulatory requirements. You will lead the transition from traditional document control to a Digital Project Delivery model, ensuring high data integrity and seamless information exchange across a global portfolio of capital projects.

Requirements

  • Master’s or Bachelor’s degree in Engineering, Information Science, or a related technical discipline.
  • Minimum of 8–10 years of experience in technical document or information management, ideally within the Pharmaceutical or Biotech industries.
  • Subject matter expert in BIM Level 2/3 requirements and the ISO 19650 suite of standards for information management.
  • Advanced proficiency with Enterprise Content Management platforms such as OpenText, Veeva Vault, or Autodesk Construction Cloud.
  • Comprehensive understanding of GxP, the validation lifecycle (V-Model), and ALCOA+ data integrity principles.
  • Skilled at leading cross-functional teams and managing external vendors within a complex, global matrixed environment.
  • Possess the strategic vision necessary to anticipate the evolution of digital engineering and translate complex requirements into structured information architectures.

Responsibilities

  • Define and maintain the Global Engineering Document Management strategy, ensuring full alignment with ISO, GxP regulatory requirements, and internal Roche standards.
  • Establish comprehensive document control procedures, including standardized metadata, taxonomies, and lifecycle workflows from Work-in-Progress to Archiving.
  • Oversee the "Handover to Operations" process to guarantee that all technical documentation is audit-ready and seamlessly integrated into Site Facilities Management systems.
  • Serve as the functional lead for the Common Data Environment (CDE), facilitating interoperability between document management systems and BIM workflows.
  • Lead periodic audits and provide rigorous oversight for external EPC partners to ensure strict adherence to corporate information and quality standards.
  • Act as the primary liaison between Global Engineering, IT, Quality Assurance, and Legal departments to harmonize digital information management.
  • Drive the evolution of digital project delivery by implementing digital twins and automated metadata extraction to reduce information loss during transitions.

Benefits

  • Relocation benefits not available for this position

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What This Job Offers

Job Type

Full-time

Career Level

Senior

Education Level

Associate degree

Number of Employees

5,001-10,000 employees

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