Document Management Systems Manager

Job Description:

Responsibilities

•  Global Service Oversight: Manage workload, priorities, and resource planning across a global service model.
•  Document Lifecycle Management: Oversee end-to-end document lifecycle processes (creation, review, approval, effective, archival) ensuring timely and compliant execution.
•  Compliance: Ensure adherence to GxP requirements and Good Documentation Practices (GDP/ALCOA+).
•  System Administration: Ensure effective operation of the eDMS (e.g., Veeva), including workflows, templates, and metadata structures.
•  Performance Monitoring: Define and monitor KPIs (cycle times, right-first-time, data accuracy), analyze trends, and drive improvements based on insights.
•  Reporting: Provide regular reporting to leadership on system performance and compliance metrics.
•  Training & Capability Building: Ensure team and users are trained on eDMS processes and GDP requirements. Build team capability to deliver services across global stakeholders and time zones.
•  User Support: Oversee the global DMS user support request process (F11 requests) and provide guidance to document authors and users.
•  Continuous Improvement: Identify and lead implementation of process improvements and system enhancements to increase efficiency and compliance.
•  Global Super User Role: Act as global administrator of the eDMS, managing ownership of documents, workflows, and metadata.
•  Approval Gatekeeper: Act as the final approver for global documentation during approval workflows, ensuring compliance with administrative rules.
•  Cross-Functional Collaboration: Manage review and approval workflows across QA, Manufacturing, QC, Engineering, and Regulatory Affairs.
•  System Transition Support: Support cleanup activities and preparation for new eDMS implementations.
•  Other Duties: Perform additional tasks as required to support global quality systems. 

Qualification & Expeirence

•  Bachelor’s degree or higher in Chemistry, Biochemistry, or Pharmacy.
• Experience & Skills
•  Experience with Quality System Management in GMP-regulated environments.
•  Background in (Bio)pharmaceuticals or similar highly regulated industry.
•  Self-starter with solution-driven mindset.
•  Strong communication and influencing skills in international environments.
•  Project management experience is a plus.
•  Green Belt certification is a plus.