Quality Lead (f/m/d), GDD, Schaftenau, Austria
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 key responsibilities:
Your responsibilities include, but are not limited to:
• Drive the maintenance and expansion of the medical device certifications guided by the product portfolio, as well as the evolving worldwide requirements.
• Represent Novartis in the interactions with Notified Bodies.
• Act as deputy for the Medical Device Management Representative.
• Prepare for and host medical device audits and inspections, maintaining continued readiness across all functions involved.
• Support Medical Device Quality Management Reviews according to ISO and other relevant regulatory requirements.
• Provide quality assurance and compliance oversight for the life cycle management of assigned medical device portfolio.
• Maintain the oversight of the quality management system in its continual improvement cycles.
• Develop, drive or contribute to key quality plan initiatives and projects.
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 10 years’ pharma quality, medical devices or operations or Master’s Degree with more than 5 years’ pharma quality, medical devices or operations experience
• At least 5 years of experience in the field of medical devices
• Coordination and participation in Audits
• Excellent communication and stakeholder management skills
• Excellent knowledge on Regulatory matters
• Fluent in English
• Previous working experience at Notified Bodies
• 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 ₠ 66.526,88 /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.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.
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