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Senior eCompliance Manager DIT

Keywords / Skills : IT Security, Quality, Compliance, eCompliance Manager DIT

10 - 15 years
Posted: 2018-10-17

Job Description
Senior eCompliance Manager DIT

"Why Novartis:

927 million: The number of lives we touched in 2017.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.

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

Senior eCompliance Manager is responsible for providing Quality Assurance support and advisory services with regard to computerized systems validation (CSV), operating within the framework of regulations (GxP, 21CFR11, etc.) and requirements defined in the Novartis Quality Manual and global procedures. eCompliance provides the single point of contact for guidance on CSV related topics and related information. Reviews and/ or approves the global Computerized Systems key validation deliverables and changes for global systems and projects. The Senior eCompliance Manager is involved in advising and supporting major strategic initiatives governing GxP computerized systems in the area of their responsibility.

1. Ensure implementation of the NBS QA eCompliance strategy and all applicable Novartis and regulatory requirements for GxP regulated computerized systems related to Development IT (DIT) portfolio.

2. Advise strategic projects on validation strategies including novel approaches to quality assurance.

3. Single Point of Contact for all CSV related matters for GxP Global Computerized Systems and act as an interface between IT and Business for eCompliance topics in relation to GxP classified Computer Systems promoting a Quality Culture.

4. Review and approve project related documents for Global GxP relevant systems including determination of GxP applicability for all Global GxP and non-GxP relevant systems.

5. Establish trusted partnership with Development IT (DIT) with understanding of business drivers, strategic roadmap and its impact on the NBS Quality eCompliance team.

6. Ensure that eCompliance support is planned for and available for projects.

7. Ensure that life-cycle activities of the global GxP systems in scope are planned for and appropriately supported (e.g.: periodic re-evaluation of the validation status, change controls, deviations management) 8. Ensure that relevant documentation is in place and maintained according to the Novartis requirements. 9. Collaborate with GCA for on-going review of GCA audits related to CSV and Data Integrity (DI) observations. Ensure feedback into QM trigger process for any updates as necessary.

Minimum requirements

Degree in Information Technology, Life Sciences, Pharmacy or Engineering; Advanced degree preferred Fluency in English (oral and written), additional language(s) a plus.

-A minimum of 10+ years of relevant experience in the Pharmaceutical Industry or another regulated industry and in particular in regulated functions such as Quality, Compliance and/or IT Security

-Solid understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.)

-Solid experience in the development, implementation and lifecycle management of computerized systems in regulated environments

-Solid Quality experience with clinical, Regulatory (RA) and Pharmacovigilance space in view of solutions, regulatory expectations, validation approach, etc.

-Experience in validation of Cloud, SaaS platform, mobile and digital application used in regulated environments

-Successful cross-divisional/functional work with complex international teams

-Proven ability to adjust to multiple demands, shifting priorities, effectively interact and present to Management and HA inspectors

-Excellent negotiation and interpersonal skills

About Company

Novartis Healthcare Private Limited
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