The Global eCompliance Manager is responsible for providing Quality Assurance support and advisory services on behalf of the business with regard to computerized systems validation (CSV), operating within the framework of regulations (GxP, 21CFR11, etc.) and requirements defined in global procedures. QA/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 Global eCompliance Manager is involved in advising and supporting major strategic initiatives governing GxP computerized systems in the area of his/her responsibility.
Your responsibilities include, but are not limited to:
1. Ensure implementation of the NBS QA eCompliance strategy and all applicable Novartis and regulatory requirements for all GxP regulated computerized systems.
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 assigned IT Function with understanding of business drivers, strategic roadmap and its impact on the NBSQ 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) ensuring that relevant documentation is in place and maintained according to the Novartis requirements.
8. Collaborate with Quality Audit for on-going review of audits related to CSV and DI observations. Ensure feedback into QM trigger process for any updates as necessary.
Minimum requirements What you'll bring to the role:
Degree in Information Technology, Life Sciences, Pharmacy or Engineering; Advanced degree preferred Fluency in English (oral and written), additional language(s) a plus.
- 15-20 years of overall experience, and a minimum 10 years of relevant experience in the Pharmaceutical Industry and in particular within regulated functions such as IT Quality and Compliance
- 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
- Experience in validation of Cloud, SaaS platform, mobile and digital application used in regulated environments
- Experience with the implementation and operation of ERP, SAP solutions is required.
- Successful cross-divisional/functional work with complex international teams
- Proven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude
- Ability to effectively interact and present to Management, health authority inspectors.