Supplier & Data Manager Medical Devices (m/f/d)

Summary

Location: Basel, Switzerland

Role Purpose:
The global Device Compliance, Systems and Operations Team, part of Global Device & Packaging Development (GDPD), needs you to accelerate one of the most diverse and innovative medical device and drug-device combination product portfolios in the pharma industry.

About the Role

Your responsibilities include, but are not limited to:

• Use and maintenance of the Standards database for Medical Devices for Drug Delivery and Drug-Device Combination Products.

• Coordination of impact assessment for changes to standards and regulations and support the technical subject matter experts.
• Maintain & improve the process with the support of the knowledge center.

• External Partner Management: qualification of all service providers and contractors
  
  
  • guidance for qualification support in drafting & negotiating quality agreements , perform Quality Risk Assessments

• Organizing exchange meetings with qualified suppliers and technical talks with new potential partners
• Managing special orders
• Supporting in SRMactivities
• Aligning withinTRD outsourcing strategy
• Communication with internal and external stakeholders
• Leading improvement initiatives
• Collaborating with Procurement
• Coordinating trainings needs

• Confidential Disclosure Agreements: coordinating all activities, acting as a single point of contact for the group, working on a regular basis with Legal.
• Lead Process Management Network meetings: manage and maintain the medical device QMS from business side, track procedure updates together with the authoring teams. Review QMS changes and create actions as needed.
• Defining and maintaining the data ontology for GDPD
• Polarion: Admin and Project Management support - maintaining global libraries.

• Collaborate with project teams to identify areas for improvement of tools and processes used to author Design Control documentation and lead those improvements.
• Consult and actively support the Project teams during the development of new products and the product lifecycle regarding regulatory and design quality assurance aspects.
• Support the project teams in preparing for self-inspections and audits in Basel

What you'll bring to the role:

• Bachelor's degree essential. Masters or higher degree desirable, e.g. Life Sciences, Engineering, Computer Sciences or similar
• 10+ years of experience in medical devices
• 3+ years of experience in Third Party Management
• Expertise with EU MDR Regulation ( EU ) 2017/745
• Leading and influencing in global matrix organization; strong communicator & listener, actively reaching out, able to understand and connect across functions
• Senior expert in medical device development and combination product.
• Strong Regulatory and Quality Assurance backgrounds
• English both spoken and written is necessary, German and French a plus Experience with audit and self-inspection supporting roles.

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards