About this opportunity
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.
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 equivalent10-15 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 operationGood 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 teamsExperience in GxP supplier qualification activitiesProven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitudeAbility to effectively interact and present to ManagementAbility to manage the key stakeholders and build trustProven 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
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 238 comparable Manager Quality roles across 73 biopharma companies.
Salary context
56 of 238 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 238 comparable roles
+ 23 more countries
Seniority mix
238 of 238 peers have a known seniority level
Therapeutic area mix
0 of 238 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.