We are the first company to achieve the EU Medical Device Regulation (EU MDR) certification. Medical device certifications are important enablers to product launches and continued market access (LCM).
Creativity and innovative mindset are key assets as regulatory framework is increasing in complexity, as well as new medical device certifications are about to be required (e.g. UK CA).
As part of our Quality Team, you will be supporting us in actively mastering our challenges and contributing towards our goal of making high-quality products available to patients all over the world. We look forward to welcoming further talent, experience and innovative mindset to enrich our team.
Your responsibilities include, but are not limited to:
• Support the maintenance of the Novartis Pharma AG certificates.
• Drive the preparedness activities for global Medical Device Inspections from Notified Bodies. Coordinates the audit team before and during inspection, if assigned as audit coordinator for an announced audit.
• Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility
• Write, review, decide on approval and/or release of GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
• Manage project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility.
• Responsible for the quality specific tasks for a Design History File and follow-up activities including support for medical device reporting to regulatory authorities. QA Oversight for LCM.
• Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.).
• Manage the implementation of new / up-dated regulations and standards into the Medical Device QMS and maintains the currency of the Medical Device QMS. Engage and support with the QMS community in the assessment, action definition and tracking.
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What you'll bring to the role:
• Bachelor's Degree with more than 5 years' pharma quality, medical devices or operations or Master's Degree with more than 3 years' pharma quality, medical devices or operations experience
• At least 3 years of experience in the field of medical devices
• Good knowledge of cGMP, working knowledge in technical development, production or QA.
• Sound scientific, technical and regulatory knowledge.
• Strong organizational and decision-making skills.
• Strong and proven ability to analyze and evaluate cGMP compliance.
• Fluent in English
• German language
766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 54,788.30 /year (on a full time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
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