Job Description

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.

Major accountabilities:
Quality oversight of operational activities of GxP systems (e.g., Changes, Periodic
Reviews, Deviations etc.,)
Provide needed support to meet the applicable Novartis and regulatory
requirements for GxP regulated computerized systems projects.
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.
Establish trusted partnership with assigned IT Function with understanding of
business drivers, and provide the needed day to day operational support.including
determination 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 are
implemented.
Contribute for the preparation of VMP and execute the plan for the systems
associated with the respective functions.
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.
Key performance indicators:
GxP relevant computerized systems are developed, implemented and
maintained according to the Novartis requirements.
On time review and approval of changes, deviations & periodic review
reports 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 inspections
without delays and issues.
Gaps in eCompliance and CSV activities are proactively identified, escalated
and 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 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.)
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 Agility, Analytical Development, Auditing, Audit Management, Business Partnering, Change Control, Continued Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Risk Management, Root Cause Analysis (RCA), Self-Awareness, Six Sigma, Sop (Standard Operating Procedure), Technological Expertise

Skills Required