About the role

Aplyr's Quick Take

This role is about managing and improving quality management systems, specifically focusing on document and training management in a regulated pharmaceutical environment. It involves overseeing compliance, coordinating document lifecycle activities, and providing training support. This is an individual contributor role with a strong emphasis on compliance and process improvement.

Good fit

Ideal candidates have 9-12 years of experience in quality management within the pharmaceutical sector, particularly with document and learning management systems. They should be detail-oriented, proactive problem solvers who can navigate complex regulatory environments.

Worth noting

The position requires significant interaction with global teams and health authorities, which may involve travel or remote collaboration. The emphasis on compliance and governance suggests a high-stakes environment that may not suit those uncomfortable with regulatory scrutiny.

Job Description 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.

Job Description

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.

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

Aplyr's read

Novartis is a Swiss-based global healthcare leader, known for its focus on innovative medicines and commitment to addressing patient needs through diverse roles.
Synthesized from recent postings & public sources

What's promising

•Novartis invests heavily in research and development, driving innovation in pharmaceuticals.
•The company offers a wide range of global career opportunities across various fields.
•Strong focus on cutting-edge therapies, including gene therapy and AI-driven solutions.

What to watch

•Regulatory challenges can impact the speed of drug approval and market entry.
•High competition in the pharmaceutical industry requires constant innovation to maintain market position.
•Complex organizational structure may slow decision-making processes.

Why Novartis

•Novartis has a robust pipeline of innovative medicines, setting it apart in the healthcare sector.
•The company emphasizes a diverse and inclusive workplace culture across its global operations.
•Novartis is a leader in digital transformation within pharmaceuticals, integrating AI and data science.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Novartis

Novartis

novartis.com

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Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. It focuses on innovative medicines, generics, and eye care.