344247BR
May 09, 2022
Slovenia

Job Description

2.500! That’s the number of IT professionals working across all of Novartis sites all over the world! With this opportunity you will have a critical impact on the quality and compliance status of GxP regulated computerized systems.


Your key responsibilities:
• Ensure implementation of the e-Compliance strategy and all applicable Novartis and regulatory requirements for all GxP regulated computerized systems and associated infrastructure.
• Provide oversight, and guidance in the development and implementation of Novartis GxP computerized Systems and processes, including on-going implementation of Data Integrity technical controls within TT systems landscape.
• Act as Single Point of Contact for all CSV related matters for GxP Global Computerized Systems and act as an interface between TT and Business for eCompliance topics in relation to GxP classified Computer Systems promoting a Quality Culture.
• Establish trusted partnership with assigned TT Function with understanding of business drivers, strategic roadmap and its impact on the GQS eCompliance team.
• Review and approve project related documents for all Global GxP relevant systems including determination of GxP applicability. Review and approve High Level Risk Assessments (HLRA), standards and documents for all Global GxP and non- GxP relevant systems including determination of GxP applicability.
• Support the life-cycle of GxP computerized systems with periodic re-evaluation of the validation status, change controls, deviations management ensuring that relevant documentation is in place and maintained according to the Novartis requirements.
• Provide the needed e-Compliance support for the Strategic Projects, audits and Inspections. Support the measurement of KQIs and execution of DI Plan.
• Support the roll out of Computer Software Assurance (CSA) framework for the responsible TT function.

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:
• 8+ years of overall experience, and a minimum 5 years of relevant experience in the Pharmaceutical Industry and in particular within regulated functions such as IT Quality and Compliance
• Profound understanding of global regulations and Health Authorities expectations governing computerized systems. This would include computerized systems validation, lifecycle management and 21 CFR Par 11 requirements
• Solid experience in the development, implementation and lifecycle management of computerized systems in regulated environments and proficient English
• Experience in quality management of onsite, Cloud, SaaS platform, mobile and digital application used in regulated environments
• Good understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.)

Desirable requirements:
• Degree in Life Sciences, Pharmacy, Engineering or Information Technology; advanced degree preferred
• Experience in the development, implementation and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure space (e.g. ERP/SAP, MES, LIMS, CRM, IAM, etc.)


You’ll receive
Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Sports Club Membership, employment at Top SI Employer, Unlimited learning and development opportunities.


We offer permanent employment, with 6 months of probation period.

You are kindly invited to submit your application in English language, including CV by 1st of June 2022.

Why Novartis?

769 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!

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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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


Imagine what you could experience at Novartis and learn more at Novartis Teams and Skills I Novartis
CTS
TT CTS
Slovenia
Ljubljana
Quality
Full Time
Regular
No
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344247BR

eCompliance Manager (m/f/d)

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