May 17, 2022
United Kingdom

Job Description

500+! The number of ongoing clinical trials being overseen by the Novartis Global Drug Development organisation. Join us and help to transform lives as we develop innovative and life saving medicine. We are now hiring a Senior Manager, Quality Assurance to join our Precision Medicine Team. This role will work remotely to cover the Quality Assurance responsibility for Precision Medicine (PM) programs, including outsourced activities. This includes providing quality governance for PM programs, which is critical for the on-going compliance with Health Authority requirements and expectations.

Your responsibilities:
Your responsibilities include, but are not limited to:
• Support strategic Quality oversight for Precision Medicine (PM) with regards to biomarker and potential biomarker diagnostic tools development in order to ensure compliance with the Health Authorities requirements and appropriate internal quality system standards.
• Provide QA expertise and guidance to ensure compliance with requirements of the quality system are met for all programs for both internal programs and PM partner programs.
• Provide QA oversight for trial support to ensure ongoing compliance with Health Authorities requirements.
• Promote a speak-up culture with both internal and external business partners and drive the right level of compliance accountability in the assigned areas.
• Provide proactive QA oversight and guidance to Novartis clinical trial partners and design, development & manufacturing partners to ensure appropriate compliance to Health Authorities requirements
• Provide quality assurance/compliance support to assigned Program Teams.
• Provide support to PM partners for review and approval of Design Inputs for adherence to Quality System Regulation Design Controls requirements.
• Provide support to help create and maintain all aspects of the quality system.
• May have responsibility for assisting in setting up the productions and process controls system for the manufacturing of the program device. This includes setting up the Device History Records to show compliance with the Device Master Record requirements.

Diversity & Inclusion / EEO

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:
• BSc Degree in Science or Engineering
• Languages: Fluency in English (oral and written)
• Familiarity with regulatory and compliance requirements for diagnostic tests
• 5 to 7 + years of Quality Assurance/Engineering (Design Controls) in an in-vitro diagnostic (IVD)/ Medical Device environment, including embedded software of the device, Medical Device Manufacturing experience is also valuable Preferred knowledge and competency in:, ISO 13485, ISO 14971, ISO 15189.
Flexibility to travel approx 25%

Desirable requirements:
• In-vitro diagnostics, drug development, clinical trial, diagnostic testing laboratory experience is highly desirable for success in this role.
• ASQ CQE/CQA Certification is valuable, but not essential.

You’ll receive:

Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.

Why consider Novartis?
769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

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

Imagine what you could do at Novartis!

For the Ninth consecutive year, Novartis been certified a ‘Top Employer’ in the UK (2014-2022)!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

We are Novartis. Join us and help reimagine medicine.
#LI-NOV = Novartis
Global Drug Development
United Kingdom
Full Time
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Senior Manager, Quality Assurance Precision Medicine

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