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.

Responsibilities

Provide strategic and operational leadership for global GxP documentation and training programs, ensuring effective use and governance of the enterprise Electronic Document Management System (EDMS) and Learning Management System (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

Qualifications

Education Qualifications
Bachelor's Degree Bachelor's degree required. Higher level degree preferred. 

Experience Qualifications
7 or more years of professional pharmaceutical industry experience managing GxP document management and training activities in the pharmaceutical or biotech industry, or equivalent experience is required.
Must have proven years experience working with GXP principles required 
Demonstrated experience working in Veeva Quality Docs & ComplianceWire strongly preferred. 
Musthave organization awareness (e.g., interrelationship of depts., business priorities), including significant experience working cross-functionally and in global teams across different regions of the world 
Expertise with participation in regulatory inspections presenting or defending subject matter area in audits or regulatory inspections. 
Must have a strong understanding and familiarity with FDA, EMA, MHRA, and other European and international regulatory requirements, guidelines 
Must have strong software and computer skills and MS Office applications (proficient in Teams, Excel) 
Must have a proactive and positive approach to providing solutions 
Must have the ability to operate independently and to make informed decisions 
Proven ability to work with cross-functional teams in a matrixed global environment. 

Must have the ability to participate on international meetings in early morning and late evening via MS Teams

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