Summary:
As a senior experienced Quality Management Systems (QMS) specialist drive efficiency and productivity gains through contributing to the implementation of recent processes to administer a validated Global Learning Management System (LMS) and Document Man-agement system (DMS) covering multiple GxP areas in full alignment with Development and QA business goals and strategic objectives.
- Management of Development (Clinical) GxP Document Lifecycle Management and Training content in LMS achieving full regulatory compliance.
About the Role:
Major Accountabilities:
- Lead end-to-end documentation lifecycle management in DMS as CR/SOP Manager, ensuring compliance with global QMS standards.
- Coordinate, monitor, and prioritize Global Drug Development (GDD) document lifecycle activities across functions.
- Partner with Integration Leads to drive QMS transition for new entities, including SOP lifecycle and training alignment.
- Collaborate with Global Process & Governance Board (GPGB) to assess procedural changes, risks, impact, and prioritization.
- Provide training, guidance,
and support to document authors and stakeholders on DMS/1-DMT processes and standards.
- Deliver SME support during health authority inspections and audits, ensuring readiness and compliance.
- Manage change requests (CRs) in 1-DMT, including tracking metrics, overdue actions, and continuous improvement.
- Oversee training document lifecycle in LMS, including SOP updates, withdrawals, and role assignments.
- Administer Learning Management System (LMS) operations—user access, training assignments, and role management.
- Drive system governance and compliance by adhering to LMS/DMS guidelines and enabling effective training execution.
Minimum Requirements:
- 9 to 12 years of relevant experience in pharmaceutical/public health sectors (Quality, HR, or Training domains).
- Proven expertise in Document Management Systems (DMS) and Learning Management Systems (LMS) in regulated environments.
- Strong