Quality Assurance Lead - Technology and Therapeutics

927 million. That is how many lives our products touched in 2017. And while we are proud of that fact, in this world of digital and technological transformation, we must ask ourselves this: how can we continue to improve and extend even more people’s lives? 

 

What you’ll be doing

 

In this role you will collaborate with research, IT, technical and clinical operations teams to provide expert quality knowledge for the implementation of digital technologies and therapeutics such as mobile apps, medical devices, sensors, artificial Intelligence (AI) and other technologies  These products will be used for the conduct of clinical trials including remote trials.  You will work closely with research and clinical business partners and other stakeholders (Internal and External) to bridge from research to exploratory and early development clinical activities.

 

In this role, you will:   

 

• Collaborate and contribute to the Research & Clinical Innovation and Digital Program Pipeline and participate in the evaluation assessment of the innovation to assure compliance with cGxP and Novartis requirements

 

• Ensure that we conduct exploratory clinical trials and internal processes in compliance with all applicable cGCP regulations and guidelines.

 

• Provide expert Clinical Quality Assurance knowledge within Research and early development teams in order to facilitate users’ guidance and quality considerations of best practices.

 

• Ensure implementation of Quality Agreements appropriate to the innovation and data quality opportunities.

 

• Keep abreast of new regulations/requirements through the active review of the current compliance-based literature

 

What you will bring to the role: 

 

• Delivery of quality knowledge to assure expedited execution business & Quality innovation strategy

 

• Reduce the risk for the business to be out of compliance. 

 

• Timely participation and provision of Expert Quality knowledge is critical to the continued success of the innovation projects.

 

• Optimization of overall QA performance

We are looking for people with:

 

• Masters of Science in IT/Engineering/Scientific discipline and/or Ph.D. in a Scientific and/or Engineering discipline preferred

 

• Seven  or more years of experience working in R&D Quality in Pharmaceutical, Medical Device or Biotech industry 

 

• In-depth knowledge of Industry Quality Standards (GCP, ICH, FDA Part 11, ISO 13485)

 

• Broad knowledge of IT/Software/Medical Device regulations including practical experience. 

 

• Experience in Digitalization clinical projects considered a plus.

 

What Novartis can offer you?

Yes, we offer exceptional benefits and competitive salaries. However, we can offer more.  Here you will:

 

• Work on interdisciplinary projects with a wide range of business functions and successfully work in global cross-functional matrix.

 

• A clear sense of personal accountability, an ability to empower people, ability to drive quality culture with partners and a high degree of mutual respect and integrity are essential factors to succeed.

 

• Innovative, analytical, conceptual & solution-oriented mindset.

 

• An organization with strong customer focus and quality driven

 

• Work with the latest technologies

 

• Work with industry thought leaders on a regular basis

 

Why consider Novartis? 

 

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you are given opportunities to explore the power of digital and data. Where you are empowered to risk failure by taking smart risks, and where people who share your determination to tackle the world’s toughest medical challenges surround you. 

 

We are Novartis. Join us and help us reimagine medicine.

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.