Principal Archivist, Research Quality (Director) - Takeda : Job Details

Job Title: Principal Archivist, Research Quality

Location: Cambridge, MA

The Principal Archivist is a member of the Research Quality leadership team and is responsible for the strategy, management, operation, and procedures related to archival of information, documentation, records, and other materials associated with Research activities in Takeda R&D. The responsibilities of this position encompass strategic management, efficient operation, and meticulous procedural oversight of the archival function to ensure compliance with company quality standards and global regulatory requirements. The Principal Archivist contributes to company success by employing deep expertise in archival sciences to lead the archiving strategy across the global Research enterprise, ensure compliance, and implement harmonized & effective systems, standards, and processes for storage, retrieval, and traceability.

• Provide strategic leadership in defining the vision, framework, and requirements for the R&D archival program, working across the global enterprise with key stakeholders (e.g., in Research, Global Quality, Pharmaceutical Sciences, Plasma-Derived Therapies) to implement, as well as ensure execution and compliance to Takeda standards and global Good Laboratory Practice (GLP) regulations [e.g., 21 CFR Part 58; OECD (Organization for Economic Co-operation & Development) Principles of GLP].
• Leverage a comprehensive understanding of archival requirements/best practices in a biopharmaceutical environment to develop, implement, and maintain contemporary measures to safeguard archived materials and data integrity, thereby ensuring full traceability, security, and retrievability of vital data/records used to support Takeda's global regulatory filings.
• As the primary archival subject-matter-expert (SME) in Takeda, works across functional areas to provide guidance and ensure business-level performance and execution of the review of archival submissions for completeness and accuracy and assurance that materials are organized, traceable, and maintained properly while archived.
• Set the strategy for evaluating current archival best practices in the global biopharmaceutical industry, identifying potential gaps and risks within Takeda, and implementing solutions which ensure comprehensive efficient record-keeping principles, governance, compliance and audit-readiness.
• Lead the creation and maintenance of archiving procedures and an archive system/database which ensure indexing, traceability, and expedient retrieval of archived material (e.g., raw data, documentation, protocols, reports etc.) supporting Takeda regulatory filings, intellectual property protection, publications, and similar activities of biopharmaceutical research and development.
• Ensure alignment and compliance across Takeda's document and record retention policies through interface with Records Information Management, IT, Clinical Operations and related functions.
• Establish processes and procedures for managing external archiving service vendors, ensuring accountable tracking, flow, and disposition of all externally archived materials.
• Pioneer the development and integration of innovative solutions, cutting-edge technologies, and process optimization to deliver the “archive of the future” across Takeda.
• Serve as SME during mergers, acquisitions, divestitures, and reorganizations so that Research-related information assets are correctly and securely managed.
• Monitor the evolving landscape of regulations and global industry trends pertinent to archiving, communicate effective impact assessments, and develop mitigation plans to ensure Takeda remains in a constant state of compliance.
• Additional duties as assigned.

• Minimum requirements:

  • Bachelor's degree in Archival Studies, Library Sciences, or similar
  • 8+ years of experience in archival/records management/administrative positions
  • Experience working in biotech/pharmaceutical research or similar regulated environment

• Preferred requirements:

  • Advanced degree in Archival Studies, Library Sciences, or similar
  • Certification in Records Management or Information Management (e.g., Certified Records Manager, NARA Records Certification, AIIM records related certification, Enterprise Content Management Specialists)

• Desired skills & competencies:

  • Deep knowledge and expertise in GLP archival regulations, records/information management, and/or Federal laws, policies, and procedures relating to records management.
  • Versatility, flexibility, and willingness to work within a dynamic environment; ability to manage and complete multiple projects in a timely manner.
  • Strong leadership, collaboration, and influencing skills; demonstrated ability to problem solve and drive positive change.
  • Ability to deal effectively with a diversity of individuals at all organizational levels.
  • Excellent interpersonal, oral, and written communication skills; ability to successfully interact with key internal stakeholders and vendors.
  • Expert-level of proficiency in archival/records management software, Microsoft PowerAutomate tools and related applications to drive automation.
  • Proven attention to detail and organizational skills
  • Ability to work independently across a global environment and navigate through organizational complexities.