eCompliance Manager

AI in this role

Provide quality assurance oversight for computerized systems validation while driving automation and AI-enabled solutions.

computerized-systems-validationgxpquality-assurancecomplianceautomation

Job Description Summary

About the role:

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.

Job Description

Key Requirements:

Quality oversight of operational activities of GxP systems (e.g., Changes, Periodic Reviews, Deviations etc.,)
Drive the design, deployment and continuous improvement of automation and AI-enabled solutions within assigned processes.
Provide needed support to meet the applicable Novartis and regulatory requirements for GxP regulated computerized systems projects.
Supports the development of future-focused strategy in AI and emerging technologies readiness, evaluating regulatory requirements and developments to ensure Novartis QMS is fit for purpose in the eCompliance environment.
Point of Contact for all CSV related matters for GxP 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.
Review and approve project related documents for GxP relevant systems including determination of GxP applicability for all GxP and non-GxP relevant systems.
Establish trusted partnership with assigned IT Function with understanding of business drivers, and provide the needed day to day operational support.
Review and approve the GxP Changes and the associated deliverables. Review and approve the GxP impacted deviations, ensure appropriate CAPA are implemented.
Review and approve the Periodic Review Reports for the GxP computerized systems and the associated gaps within CAPA Management System. Perform supplier qualification assessment activities.
Provide Audit support as assigned and in case of CAPAs, provide the required Quality support.

Essential Requirements:

Degree in Information Technology, Life Sciences, Pharmacy, Engineering or equivalent
10-15 years of overall IT experience, and a minimum 7 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 quality management of Cloud, SaaS platform, mobile and digital application used in regulated environments
Highly experienced in the operational management of GxP solutions including its related technologies to support the operation
Good understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.)
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.)

Desirable Requirements:

Successful cross-divisional/functional work with complex international teams
Experience in GxP supplier qualification activities
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
Ability to manage the key stakeholders and build trust
Proven ability to influence without hierarchical authority and build trusted partnerships
Proven self-starter with experience in initiating and delivering projects and processes
Excellent communication, negotiation, facilitation, and interpersonal skills

Skills Desired

Audits Compliance, cGMP Compliance, Collaboration, Communication, Data Integrity, Decision Making, Internal Auditing, Managing Ambiguity, Problem Solving, Quality Assurance (QA), Quality Auditing, Quality Compliance, Quality Management, Quality Management System Implementation, Quality Management Systems (QMS), Regulatory Compliance, Risk Management, Validation Activities

How we rate this

eCompliance Manager at Novartis rates 45 out of 100 for how much of the daily work is AI. That makes it Uses AI (AI Level 2 of 4). The level is about AI in the job, not seniority.

Classification

Uses AI. An ordinary role that requires AI tools.

●●●● Builds AI80 to 100
●●●○ Works on AI60 to 79
●●○○ Uses AI40 to 59
●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Open the description and count.

Prepare for this job

A free preview built only from this posting: what it asks for, what you could be asked in an interview, and how to adjust your resume.

Skills and AI tools this role asks for

Computerized Systems ValidationGxpQuality AssuranceComplianceAutomation

Questions you could be asked

Tell me about a project where computerized systems validation was part of your work. What did you do?
Tell me about a project where gxp was part of your work. What did you do?
Tell me about a project where quality assurance was part of your work. What did you do?
Tell me about a project where compliance was part of your work. What did you do?
Tell me about a project where automation was part of your work. What did you do?

Adapt your resume

List these exact terms on your resume: Computerized Systems Validation, Gxp, Quality Assurance, Compliance, and Automation. An applicant tracking system matches the wording, not the idea.
Attach one line of real, concrete experience to at least one of them — a tool named with nothing behind it rarely survives a human read.
Put the AI tool in a bullet point about what you did, not just in a skills list — this role treats it as a required part of the job.

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