{"id":3236106,"url":"https://alion.io/job/novartis-ecompliance-manager","title":"eCompliance Manager","company":{"id":5824,"name":"Novartis","domain":"novartis.com","url":"https://alion.io/company/novartis","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":81,"open_postings":61,"ghost_share":0,"stale_share":0.754,"repost_share":0.016,"time_to_fill_p50_days":28,"computed_at":"2026-10-28T05:59:10Z"}},"role":"Management","role_family":"Management","seniority":"staff","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Hyderabad, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":24000,"max_usd":52000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":13},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"IAM","optional":false},{"name":"ITIL","optional":false},{"name":"ITSM","optional":false},{"name":"LIMS","optional":false},{"name":"GMP","optional":true}],"status":"live","first_seen_at":"2026-10-22T00:00:00Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-28T17:12:03Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"Job Description Summary\nAbout 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.\neCompliance 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.\nJob Description\nKey Requirements:\nQuality oversight of operational activities of GxP systems (e.g., Changes, Periodic Reviews, Deviations etc.,)\nDrive the design, deployment and continuous improvement of automation and AI-enabled solutions within assigned processes.\nProvide needed support to meet the applicable Novartis and regulatory requirements for GxP regulated computerized systems projects.\nSupports 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.\nPoint 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.\nReview and approve project related documents for GxP relevant systems including determination of GxP applicability for all GxP and non-GxP relevant systems.\nEstablish trusted partnership with assigned IT Function with understanding of business drivers, and provide the needed day to day operational support. \nReview and approve the GxP Changes and the associated deliverables. Review and approve the GxP impacted deviations, ensure appropriate CAPA are implemented.\nReview and approve the Periodic Review Reports for the GxP computerized systems and the associated gaps within CAPA Management System. Perform supplier qualification assessment activities.\nProvide Audit support as assigned and in case of CAPAs, provide the required Quality support.\nEssential Requirements:\nDegree in Information Technology, Life Sciences, Pharmacy, Engineering or equivalent\n10-15 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\n Solid understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.)\nSolid experience in the development, implementation and lifecycle management of computerized systems in regulated environments\nExperience in quality management of Cloud, SaaS platform, mobile and digital application used in regulated environments \nHighly experienced in the operational management of GxP solutions including its related technologies to support the operation\nGood understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.)\nExperience 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.)\nDesirable Requirements:\nSuccessful cross-divisional/functional work with complex international teams\nExperience in GxP supplier qualification activities\nProven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude\nAbility to effectively interact and present to Management\nAbility to manage the key stakeholders and build trust\nProven ability to influence without hierarchical authority and build trusted partnerships\nProven self-starter with experience in initiating and delivering projects and processes\nExcellent communication, negotiation, facilitation, and interpersonal skills\nSkills Desired\nAudits 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","description_format":"text","description_chars":4532,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Oncology Therapeutics","Neurology & CNS Therapeutics","Immunology & Inflammation Therapeutics","Cardiometabolic 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