Supplier & Data Manager Medical Devices (m/f/d)
Basel (City)
Novartis
Working together, we can reimagine medicine to improve and extend people’s lives.Job Description Summary
Location: Basel, SwitzerlandRole 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.
Job Description
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 SRM activities
- Aligning within TRD 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 plusExperience 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.
Skills Desired
* Salary range is an estimate based on our AI, ML, Data Science Salary Index 💰
Tags: Engineering Pharma
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