Global QMS RDQ Senior Specialist Summary As a senior experienced Quality Management Systems (QMS) specialist drive efficiency and productivity gains through contributing to the implementation of new 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.

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 recent 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.

Skills Desired Collaboration, Communication Skills, Continuous Improvement mindset, Data Integrity, Dealing With Ambiguity, Decision Making, Digital saviness, Leadership, Problem Solving Skills, Project Management, Regulatory Requirements knowledge, Risk Management Experience Level Senior Level

📌 Senior Quality Management Systems Specialist - Global Regulatory Document & Training (Hyderabad)
🏢 Novartis India
📍 Hyderabad