Senior Quality Management Systems Specialist - Global Regulatory Document & Training

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 understanding of GxP regulations, health authority expectations, and compliance frameworks.
• Demonstrated ability to drive global quality systems and implement robust governance processes.
• Excellent leadership, communication, stakeholder management, and problem-solving skills.
• Ability to influence change, drive innovation, and operate effectively across a global, matrixed organization.