Document Management Systems Manager

Document Management Systems - Manager

Job Description Summary:

As a Global Quality Systems Manager, you will lead the global electronic Document Management System (eDMS), ensuring compliant, efficient, and standardized document management processes. This role safeguards data integrity, inspection readiness, and business performance by overseeing global workflows, training, and continuous improvement initiatives. You will act as a global super user and administrator, driving harmonization across sites and functions while ensuring adherence to GxP and Good Documentation Practices.

• 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.

• Local QMS Representatives

• Global Quality

• DMS Users

• Direction: Establishes methods and procedures for attaining specific goals and objectives, receiving guidance in terms of broad goals. Only final results are typically reviewed.

Education

• 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.

• Agility: Challenges the status quo, embraces new initiatives, and drives successful implementation.

• Business Acumen: Uses knowledge to make correct and timely decisions.

• Collaboration: Seeks diverse perspectives, shares knowledge, and builds strong networks.

• Customer Focus: Understands customer needs and manages relations professionally.

• Driving Results: Helps peers overcome obstacles, secures stakeholder buy-in, and ensures timely delivery.

• Leadership: Creates a positive work environment, demonstrates integrity, and ensures clear communication.

• Quality: Ensure adherence to global quality procedures.

• Safety: Ensure adherence to global and site safety procedures.

At Lonza, quality systems are the backbone of compliance and operational excellence. Our Global Quality Systems Managers play a critical role in ensuring that documentation processes are standardized, inspection-ready, and aligned with industry best practices. Guided by our values—Collaboration, Accountability, Excellence, Passion, and Integrity—we foster innovation and continuous improvement. By joining Lonza, you will help shape the future of global quality systems and contribute to the medicines of tomorrow.