eCompliance Manager

Novartis AG; Hyderabad; On-site; INR 2,400,000 - 4,200,000; Full time

Job summary

Novartis Healthcare Private Limited in Hyderabad seeks an eCompliance Manager to provide QA oversight for CSV and GxP systems. You will guide regulatory compliance efforts, approve critical validation deliverables, and support IT and business teams on eCompliance topics in a fast-paced pharma environment.

The role requires 10–15 years in IT with 7+ years in regulated pharma settings, including knowledge of CSV, 21 CFR Part 11, and cloud and digital applications used in GxP contexts.

Qualifications

• Degree in IT, life sciences, pharmacy, engineering or equivalent.
• 10–15 years IT experience with 7+ years in Pharma IT quality/compliance.
• Solid understanding of CSV, Part 11 and global regulations for GxP systems.

Responsibilities

• Provide quality oversight of GxP systems operations (changes, reviews, deviations).
• Approve CSV-related deliverables and associated CAPAs for projects.
• Interface between IT and business on eCompliance topics in GxP systems.
• Review Periodic Review Reports and GxP changes for compliance.
• Support supplier qualification and audit activities as needed.

Skills

Quality assurance

GxP

IT quality

Stakeholder management

Regulatory compliance

Education

Degree in IT/Life Sciences/Engineering

Job description

SummaryAbout 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.About the RoleKey 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 environmentsExperience in quality management of Cloud, SaaS platform, mobile and digital application used in regulated environmentsHighly 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 partnershipsProven self-starter with experience in initiating and delivering projects and processesExcellent communication, negotiation, facilitation, and interpersonal skillsWhy Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureBenefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.Read our handbook (PDF 30 MB)DivisionOperationsBusiness UnitQualityLocationIndiaSiteHyderabad (Office)Company / Legal EntityIN10 (FCRS = IN010) Novartis Healthcare Private LimitedFunctional AreaQualityJob TypeFull timeEmployment TypeRegularShift WorkNoAccessibility and accommodationNovartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [e-mail] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.