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Ecompliance Manager

Novartis
Novartis
10-15 years
preferred by company
Hyderabad
1 May 6, 2026
Job Description
Job Type: Full Time Education: Bachelor’s Degree or Master’s Degree in: Information Technology Computer Science Software Engineering Pharmacy Biotechnology Life Sciences Quality Assurance Regulatory Affairs Or related disciplines Skills: Auditing, Audit Management, Audits Compliance, Communication, Continued Learning, Decision Making, Gmp Procedures, Inspection Readiness, Managing Ambiguity, Organizing, People Management and Leadershi

eCompliance Manager

Location: Hyderabad (Hybrid Office Model)
Job Type: Full-Time
Experience Required: 10–15 Years in IT Compliance, Quality Assurance, or Regulated GxP Environments
Industry: Pharmaceutical / Quality Assurance / Regulatory Compliance / Information Technology


Job Overview

We are seeking an experienced and highly detail-oriented eCompliance Manager to oversee compliance, validation, and quality assurance activities related to computerized systems within regulated pharmaceutical environments. The selected candidate will play a critical role in ensuring computerized systems remain compliant, reliable, secure, and inspection-ready throughout their lifecycle.

This role is ideal for professionals with strong expertise in computerized system validation (CSV), GxP compliance, quality oversight, cloud-based technologies, and regulatory compliance within pharmaceutical or healthcare IT environments.


Key Responsibilities

Computerized Systems Compliance & Validation

  • Provide quality oversight for day-to-day operations of regulated computerized systems.
  • Ensure compliance with:
    • Novartis quality standards
    • Global regulatory requirements
    • GxP guidelines
    • Validation standards
  • Act as the primary quality contact for computerized systems validation (CSV) activities.
  • Support validation planning, execution, and lifecycle management for computerized systems across assigned business functions.

Quality Assurance & Regulatory Oversight

  • Review and approve:
    • Validation documentation
    • System changes
    • Deviations
    • CAPAs (Corrective and Preventive Actions)
    • Project deliverables
  • Ensure inspection readiness and audit compliance across regulated systems.
  • Support:
    • Supplier qualification activities
    • Internal audits
    • Regulatory inspections
  • Maintain adherence to quality procedures, compliance standards, and industry best practices.

Technology & Digital Solutions Management

  • Support compliance oversight for:
    • Cloud-based systems
    • SaaS platforms
    • Mobile applications
    • Digital healthcare technologies
  • Collaborate with:
    • Information Technology teams
    • Quality Assurance teams
    • Business stakeholders
  • Ensure systems remain compliant throughout implementation, maintenance, upgrades, and retirement phases.

Cross-Functional Collaboration

  • Act as a bridge between:
    • Business teams
    • IT departments
    • Compliance teams
    • Operational stakeholders
  • Build effective partnerships across global and cross-functional teams.
  • Provide guidance on quality and compliance matters related to regulated technologies and computerized systems.

Risk Management & Operational Excellence

  • Support identification and mitigation of:
    • Compliance risks
    • Validation gaps
    • System quality issues
  • Ensure implementation of robust quality support models and operational best practices.
  • Promote continuous improvement and operational excellence across regulated digital environments.

Required Qualifications

Educational Qualifications

Preferred Education Level:

  • Bachelor’s Degree or Master’s Degree in:
    • Information Technology
    • Computer Science
    • Software Engineering
    • Pharmacy
    • Biotechnology
    • Life Sciences
    • Quality Assurance
    • Regulatory Affairs
    • Or related disciplines

Preferred Qualifications

  • Certifications in:
    • Computerized System Validation (CSV)
    • GxP Compliance
    • Quality Assurance
    • IT Compliance
    • Cloud Technologies
    • Regulatory Affairs
    • Audit & Risk Management
  • Additional expertise in:
    • SaaS Compliance
    • Digital Health Platforms
    • Pharmaceutical Quality Systems
    • Risk & Compliance Frameworks