Sumar
About the Role:
The purpose of the role is to be responsible for managing medical device service aspects focused to ensure accurate and timely preparation and maintenance of medical device technical documents, in accordance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements, the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures and agreed between MS&T NOCC and business partners within Operations network.
About the Role
Key Responsibilities:
- Technical documentation management (DHF, DMR, PMS)
- Risk assessment and gap analysis
- Technology transfer support
- Data analysis & visualization (Power BI)
- Data Integrity (DI) & Data Administrator (DA) checks
- Change Control management
- SaMD documentation & coordination with third-party manufacturers
- Creation/review of GxP documents (SOPs, reports, investigations)
- Audit support (internal & external)
- CAPA support and process improvement activities
- Compliance with ISO, FDA, MDR, and Novartis quality standards
Essential Requirements
- High quality output / accuracy / Right First Time
- Timely delivery of tasks
- Ability to manage deviations and escalate when needed
Desirable Requirements
- Experience with SaMD documentation
- Coordination with third‑party manufacturers
- Exposure to global operations
- Additional quality or regulatory certifications (implied)
Education
- Degree in Pharmacy, Science, Engineering, MBA, or equivalent from a reputed institute
Experience
- Minimum 6 years in MS&T, medical devices, Quality Assurance, Regulatory, or pharmaceutical manufacturing
- Strong GxP and cGMP knowledge
- Broad IT knowledge; proficient in MS Office
- Experience working with global stakeholders
- Excellent communication, presentation & analytical skills
- Project management experience
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.
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.
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
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
VIDEO
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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
