QA Team Lead Medical Devices (f/m/d), Quality, Schaftenau, Austria
In 2014 the first medical device was introduced to the market by Novartis/Sandoz, since then the portfolio for medical devices and combination products are heavily growing. Be part of the QA Medical device team and support commercialization of new devices to the markets worldwide.
As Team Lead QA Medical Devices, you and your team will support the introduction of new autoinjector devices to commercial phase and manage the device suppliers from a quality point of view. You will be responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance 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.
Your key responsibilities:
Your responsibilities include, but are not limited to:
In 2014 the first medical device was introduced to the market by Novartis/Sandoz, since then the portfolio for medical devices and combination products are heavily growing. Be part of the QA Medical device team and support commercialization of new devices to the markets worldwide.
As Team Lead QA Medical Devices, you and your team will support the introduction of new autoinjector devices to commercial phase and manage the device suppliers from a quality point of view. You will be responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance 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.
Your key responsibilities:
Your responsibilities include, but are not limited to:
- Leading the QA Medical Device group being responsible for primary packaging components, device constituent parts of Combination products and standalone medical devices
- Assuring maintenance and implementation of the Novartis Medical Device Quality Management System and international relevant guidelines
- Participating and contributing in Incident and Exception management in the field of medical devices and playing an active role in preparation and execution of GxP Audit and Health Authority Inspection management in the field of MD
- Driving the talent agenda: Leading people processes through recruitment, training, coaching and performance to meet all operational requirements and supporting a robust career path deployment and succession plan for area of responsibility
- Oversight of all production and testing activities for PPM and MDs, ensuring compliance with cGxP
- Support OpEx improvement projects
- Support Complaint Management for Medical Devices for the Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
- Support for third party management of PPM and device component suppliers
- Review and approval of DHF and DMR documents for Commercial medical devices and combination products
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum requirements
What you’ll bring to the role:
Essential:
Desirable requirements:
Why Novartis?
769 million lives were touched by Novartis medicines in 2020, 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 € 73,112.90/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.
We are open for part-time and job-sharing models and support flexible and remote working where possible.
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
Essential:
- University degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent
- Fluent knowledge of English language (written and spoken), German is an advantage
- At least 5 years or more experience in QC or QA or medical device industry
- Profound experience leading team in quality with focus on primary packaging materials and medical Devices
- Ability to speak up and to take Quality decisions during challenging situations
- Strong leadership skills with excellent interpersonal, communication and negotiation abilities, with confirmed experience in change management and integration of teams and/or organizations
- Flexibility to work in a fast paced, quickly changing work environment
- Ability to operate in a global matrix environment
Desirable requirements:
- Expertise in organization dynamics and culture, ability to gain trust and confidence at all levels in the organization, leadership, and project management experience
- Ability to work independently and effectively in international, complex, and multifaceted environments
Why Novartis?
769 million lives were touched by Novartis medicines in 2020, 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 € 73,112.90/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.
We are open for part-time and job-sharing models and support flexible and remote working where possible.
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
Division
Operations
Business Unit
QUALITY
Country
Austria
Work Location
Schaftenau
Company/Legal Entity
Sandoz GmbH
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
