Associate Manager, Document Control & Training Operations

Position Summary The Associate Manager, Document Control & Training Operations is responsible for leading and overseeing document control and training administration activities that support GxP compliance across the organization. This role serves as a key business partner to Quality, Clinical, Regulatory, Manufacturing, and other functional stakeholders to ensure controlled documents, training programs, and learning systems are managed efficiently and in accordance with applicable regulations and company standards. The Associate Manager drives operational excellence through process optimization, governance, metrics, stakeholder engagement, and continuous improvement initiatives while ensuring the integrity of document and training records. This position plays a critical role in supporting inspection readiness, compliance oversight, and scalable business processes across global operations. Key Responsibilities Document Control Leadership Lead end-to-end document control activities within the electronic document management system (eDMS), ensuring compliance with GxP regulations and company procedures. Oversee document lifecycle management, including creation, revision, review, approval, issuance, periodic review, archival, and retirement of controlled documents. Serve as a subject matter expert (SME) for document management processes and provide guidance to stakeholders on document control requirements and best practices. Monitor document workflows and proactively drive timely completion of document reviews and approvals to meet business and compliance timelines. Ensure document metadata, document hierarchies, and system records are accurate, complete, and maintained in accordance with governance standards. Identify and implement process improvements to increase efficiency, quality, and compliance of document management activities. Support inspection and audit readiness by ensuring document records are complete, traceable, and readily accessible. Training Operations & Learning Management Lead training administration activities within the Learning Management System (LMS), ensuring accurate assignment, tracking, and reporting of training requirements. Partner with business stakeholders to determine training impact assessments and appropriate learner audiences for new and revised procedures. Oversee the creation and maintenance of training curricula, learning assignments, user groups, assessments, and training records. Collaborate with process owners and subject matter experts to develop engaging and effective learning content, including e-learning modules, videos, presentations, and instructor-led materials. Monitor training compliance metrics and proactively address training completion risks. Provide consultation and support to users on LMS functionality, training processes, and system-related inquiries. Operational Excellence & Continuous Improvement Analyze operational metrics and performance indicators to identify trends, risks, and opportunities for improvement. Develop and maintain dashboards, reports, and key performance indicators (KPIs) related to document control and training compliance. Lead or participate in cross-functional initiatives focused on process harmonization, automation, digital transformation, and operational efficiency. Recommend and implement best practices that enhance scalability, compliance, and user experience. Support business continuity and change management activities associated with system implementations, upgrades, and process enhancements. Stakeholder Management & Collaboration Build strong partnerships with Quality, Clinical Development, Regulatory Affairs, Manufacturing, and other business functions. Act as a primary point of contact for document control and training operations, providing guidance, issue resolution, and escalation management. Facilitate stakeholder meetings, communicate process updates, and drive alignment on compliance and operational priorities. Influence stakeholders to adopt standardized processes and compliance-focused practices. Systems & Compliance Support Support validation activities, user acceptance testing (UAT), and system enhancements for document management and learning systems. Partner with system administrators, IT teams, and vendors to identify and resolve system-related issues. Ensure compliance with applicable GxP regulations, industry standards, and company policies. Support regulatory inspections, audits, and quality investigations as required. Leadership Responsibilities Serve as a functional lead for document control and training operational activities. Provide mentoring, coaching, and knowledge sharing to team members and business stakeholders. Drive accountability, promote continuous improvement, and foster a culture of quality and compliance. Lead projects and workstreams with minimal supervision while managing competing priorities and timelines. Qualifications Education Bachelor’s degree required. Advanced degree preferred. Experience 2+ years of experience in document control, quality systems, training administration, learning management systems, or related GxP-regulated environments. Experience supporting global organizations and cross-functional stakeholders preferred. Experience leading process improvement, operational excellence, or system implementation initiatives preferred. Technical Skills Experience with electronic document management systems (eDMS); Veeva Vault QualityDocs preferred. Experience with Learning Management Systems (LMS); SumTotal experience preferred. Advanced Microsoft Office skills, particularly Microsoft Word, Excel, PowerPoint, and SharePoint. Experience developing reports, dashboards, and metrics. Familiarity with validation testing and computerized system lifecycle activities. Competencies Strong leadership and stakeholder management skills. Excellent written and verbal communication skills in both Mandarin Chinese and English. Strong analytical and problem-solving abilities. Exceptional attention to detail and organizational skills. Ability to influence without direct authority. Proven ability to manage multiple priorities in a fast-paced environment. Demonstrated commitment to continuous improvement and operational excellence. Strong understanding of GxP regulations, quality systems, and compliance requirements. Languages Fluent in Mandarin Chinese (written and spoken). Fluent in English (written and spoken). 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