eCompliance Manager

This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Summary The eCompliance Manager is responsible for providing Quality Assurance oversight and

guidance 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 Manager provides the needed operational support such as approving the

GxP impacted changes, Periodic Review Reports, deviations etc., Provides the guidance

to the project and operations team on the CSV related topics and related information.

Reviews and / or approves the global Computerized Systems key validation deliverables

as a part of the eCompliance support to the GxP projects. About the Role Major accountabilities :

Quality oversight of operational activities of GxP systems (e.g., Changes, PeriodicReviews, Deviations etc.,)

Provide needed support to meet the applicable Novartis and regulatoryrequirements for GxP regulated computerized systems projects.

Point of Contact for all CSV related matters for GxP Computerized Systems and actas an interface between IT and Business for eCompliance topics in relation to GxPclassified Computer Systems promoting a Quality Culture.

Establish trusted partnership with assigned IT Function with understanding ofbusiness drivers, and provide the needed day to day operational support.includingdetermination of GxP applicability for all GxP and non-GxP relevant systems.

Review and approve the GxP Changes and the associated deliverables.

Review and approve the GxP impacted deviations, ensure appropriate CAPA areimplemented.

Contribute for the preparation of VMP and execute the plan for the systemsassociated with the respective functions.

Review and approve the Periodic Review Reports for the GxP computerized systemsand the associated gaps within CAPA Management System.

Perform supplier qualification assessment activities.

Provide Audit support as assigned and in case of CAPAs, provide the requiredQuality support.

Key performance indicators :

GxP relevant computerized systems are developed, implemented andmaintained according to the Novartis requirements.

On time review and approval of changes, deviations & periodic reviewreports for the GxP computerized systems.

Documentation supporting eCompliance and CSV requirements is in place,maintained up-to-date and can be presented during audits and inspectionswithout delays and issues.

Gaps in eCompliance and CSV activities are proactively identified, escalatedand the development of mitigation plans supported.

Client / stakeholder satisfaction and corresponding feedback.

Minimum Requirements : Degree in Information Technology, Life Sciences,

Pharmacy, Engineering or equivalent

Work Experience :

10-15 years of overall IT experience, and aminimum 7 years of relevant experience in thePharmaceutical Industry and in particular withinregulated functions such as IT Quality andCompliance

Solid understanding of global regulations andHealth Authorities expectations governingcomputerized systems (CSV, Part 11, etc.)

Solid experience in the development,implementation and lifecycle management ofcomputerized systems in regulated environments

Experience in quality management of Cloud,SaaS platform, mobile and digital applicationused in regulated environments

Highly experienced in the operationalmanagement of GxP solutions including itsrelated technologies to support the operation

Good understanding in system applicationmanagement, its Quality support approach andindustry best practices (ITIL, ITSM, etc.)

Experience in the development, implementationand lifecycle management of key computerizedsystems in the Pharmaceutical Development,Manufacturing, Quality, Commercial andInfrastructure space (e.g. ERP / SAP, MES, LIMS,CRM, IAM, etc.)

Successful cross-divisional / functional work withcomplex international teams

Experience in GxP supplier qualification activities

Proven ability to adjust to multiple demands,shifting priorities and unexpected events whilemaintaining a positive work attitude

Ability to effectively interact and present toManagement

Ability to manage the key stakeholders and buildtrust

Proven ability to influence without hierarchicalauthority and build trusted partnerships

Proven self-starter with experience in initiatingand delivering projects and processes

Excellent communication, negotiation, facilitation,and interpersonal skills

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