Site IT, Business Expert Quality Systems

Oct 15, 2021

Job Description

108,000 associates reimagining medicine for more than 799 million people globally!

Do you think you can find and deliver “10x” innovation opportunities in Novartis Business Services? Your passion for innovation and ability to build and lead a high-performing distributed team of associates and digital eco-system partners will help us re-imagine the next generation of NBS!

The Quality Information Technology Specialist is responsible for Quality computerized system lifecycle management from concept, development, validation, implementation, maintenance, to retirement. The incumbent will serve as domain expert for Quality computerized systems and ensure to ensure compliance to regulatory requirements, such as 21 CFR Part 11, and Annex 11. In addition, the incumbent will be responsible for the day-to-day management and continuous improvement of all QC computerized systems/processes.

What will you be responsible for?

• Act as administrator and domain expert for laboratory computerized system administration, design, and configuration including OS permissions and 3rd party tools to ensure data integrity.
• Lead QC IT projects and lab instrument system qualification.
• Work with Quality, IT, and Validation to support Quality computerized system lifecycle management activities from concept, development, validation, implementation, maintenance, to retirement.
• In addition to supporting the base site, support a harmonized approach with team members across all network sites for Quality systems.
• Author and review protocols, reports, investigations, non-conformance, CAPAs, and other records related to Quality computerized systems.
• Monitor Quality computerized systems to ensure compliance to regulatory requirements, such as 21 CFR Part 11, and Annex 11.
• Lead data integrity initiatives as they relate to Quality computerized systems.
• Lead periodic review of existing computerized systems and identify process improvements and coordinating implementation of new processes.
• Create/Maintain SOPs and training related to Quality IT systems.
• Represent Quality IT during meetings. Communicates and tracks all follow-up items through to completion.

Diversity & Inclusion / EEO

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 other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

What will you bring to the role?

• Bachelor's Degree in Scientific / Biotech / Pharmaceutical / IT field of study,
• 8+ years working in a GxP pharma or biotech environment.
• 6+ years of demonstrated ability with administration, installation, and business acceptance of new lab instrument systems (ex. Empower, LabX, Softmax)
• Familiarity with Windows permission settings, network domain, and a general understanding of server architecture
• Prefer familiarity with SQL, Java, or other LIMS programming language.
• Experience should include lifecycle management of Quality computerized systems.
• Up to 20% travel required

What you'll receive in return?

Competitive salary, annual bonus, long-term incentive for select levels, health insurance, paid vacation/holidays, potential flexible working arrangements, employee recognition scheme.

Why consider Novartis?

799 million! That’s how many lives our products touched in 2019. 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!
Durham, NC
Information Technology
Full Time
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Site IT, Business Expert Quality Systems

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