Associate Director, Documentation & Training GQA

Job Summary

The Associate Director, Documentation & Training GQA (Global QMS) reports to the Head of Documentation and Training GQA and provides strategic oversight and operational leadership for the company's regulated GxP documentation and training programs, leveraging the enterprise Electronic Document Management System (EDMS) and Learning Management System (LMS) as primary platforms. This role ensures that global quality documents and training requirements are effectively governed, deployed, and maintained in compliance with applicable global regulations and internal quality standards.

Acting as a key partner to Quality, Regulatory, IT/DX, and business stakeholders across regions, the Associate Director supports the harmonization of GxP document lifecycle management and training processes across global affiliates, including Japan, the Americas, and Europe. The role contributes to inspection readiness, data integrity, and continuous improvement by driving standardized governance models, system‑enabled controls, and effective training execution beyond completion metrics, with emphasis on application and compliance.

The Associate Director supports system validation and change management activities for EDMS and LMS platforms, oversees training strategy execution, and provides subject matter leadership to ensure reliable, compliant, and efficient use of documentation and training systems across the organization.

• Provide strategic and operational leadership for global GxP documentation and training programs, ensuring effective use and governance of the EDMS and LMS in support of the Quality Management System.
• Oversee the end‑to‑end lifecycle management of global quality documents, including standards, SOPs, and related controlled records, ensuring consistency, accuracy, and compliance with applicable global regulations and internal quality requirements.
• Lead the planning, deployment, and governance of role‑based GxP training curricula across global functions and regions, ensuring training requirements are accurately translated into LMS strategies and execution models.
• Partner with Quality, Regulatory, IT/DX, and business stakeholders to harmonize global documentation and training processes, including alignment between EDMS‑managed documents and LMS‑driven training assignments.
• Establish and maintain global governance frameworks, procedures, and metrics for documentation and training management, including oversight of effectiveness indicators beyond training completion.
• Drive continuous improvement initiatives related to documentation standards, training administration, and system‑enabled controls, informed by inspection outcomes, audit findings, and operational performance trends.
• Provide subject matter expertise and leadership to support global and regional inspection readiness, including responding to health authority inquiries related to training records, document control, and system governance.
• Mentor and influence cross‑functional partners and extended teams to promote a culture of quality, accountability, and system discipline in documentation and training practices across the organization.

• Education: Bachelor’s Degree required; higher level degree preferred.
• Experience: 7 or more years of professional pharmaceutical industry experience managing GxP document management and training activities in the pharmaceutical or biotech industry.
• Proven experience working with GxP principles and Veeva Quality Docs & Compliance Wire strongly preferred.
• Strong awareness of organizational interrelationships, including significant cross‑functional and global team experience across different regions.
• Experience participating in regulatory inspections, presenting or defending subject matter areas in audits or inspections.
• Strong understanding of FDA, EMA, MHRA, and other European and international regulatory requirements and guidelines.
• Strong software and computer skills, including proficiency in MS Office (Teams, Excel).
• Proactive, positive approach to providing solutions and the ability to operate independently and make informed decisions.
• Proven ability to work with cross‑functional teams in a matrixed global environment.
• Availability to participate in international meetings in early morning or late evening via MS Teams.

Ability to travel up to 5% both international and domestic.

USD$ - USD$

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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