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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 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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
