Global Quality Management System RDQ Specialist

Key Responsibilities

• As QMS Specialist ensures documents are in compliance with Good Documentation Practice (GDP) and internal procedures, providing a QMS review and QC check prior to final QA approval.
• As CR manager support Development Authors and track Change Requests (CRs) in 1-DMT, ensuring timely progress and release of good Quality documents in alignment with stakeholder.
• As SOP Manager for assigned Development Line Function, manage stakeholder access and approval workflow in ESOPS.
• Collaborate with global and local teams to resolve document lifecycle issues and ensure training release on time.
• Active participation in Global projects related to QMS (e.g. Global QMS simplification, CQMS Optimization) and in Global Boards (e.g. GPGV) representing RDQ QMS.
• Support governance activities by monitoring CR metrics, preparing reports, and facilitating cleanup initiatives.
• Provide support for QMS integration for newly acquired companies. SPOC for Business Line Functions for Document Lifecycle Management.
• Support audits and inspections related to QMS topics. SPOC for the QMS tools.
• Training systems document maintenance. Provide technical or administrative support for users.
• Maintain access to DLM and LMS stakeholders. Perform validation activities in 1-DMT and feed training BOT

Minimum Requirements

• Bachelor/Technical degree in Life Sciences or related fields. Advanced degree and/or MBA an advantage
• Excellent English language skills.
• Significant relevant work experience (> 5 years) in the pharmaceutical industry or public health sector, in the area of R&D, Quality, or Training.
• Demonstrated knowledge in implementing/managing robust Document management systems and Learning Management Systems, setting global quality controls in a regulated area
• Sound understanding of regulated activities, health authority expectations, and GxP, paired with good business understanding.
• Role model for the Novartis values and behaviours and exemplary interpersonal skills
• Excellent leadership, interpersonal, communication, negotiation and problem-solving skills
• Ability to innovative when faced with opportunities or challenges.
• Ability to influence and drive/facilitate changes across the organization

Why Novartis:
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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 diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/network