Job Description: Quality Manager (eCompliance)
Job ID
REQ-10078211
Date Posted
15 May 2026
Location
Hyderabad, India
Company
Novartis Healthcare Private Limited (IN10)
Division / Business Unit
Development / Development
Functional Area
Quality
Job Type
Full-time (Regular)
Shift
No
Role Summary
The Quality Manager (eCompliance) provides quality assurance expertise and operational support to ensure compliance with regulatory requirements, internal procedures, and quality standards within research and development operations.
The role focuses on eCompliance oversight, validation, inspection readiness, and quality governance for GxP and non-GxP systems.
Key Responsibilities
1. Quality Assurance & Compliance Support
Support initiatives to improve quality performance and compliance
Ensure alignment with regulatory requirements and internal quality systems
Manage risk management, IT systems, and health authority reporting support
2. Project & Quality Plan Management
Manage quality aspects of operational projects
Support third-party-related quality activities
Oversee quality plans, training, and validation activities
Support analytical instruments and manufacturing equipment quality oversight
3. eCompliance System Oversight
Provide operational support for ~20 GxP and non-GxP systems
Conduct:
Periodic reviews
Validation deliverable reviews
Change control assessments
HLCCD review and sign-off
4. System Implementation & Validation
Support implementation of new systems
Ensure compliance with validation requirements
Provide oversight for system lifecycle management
5. Vendor & IT Compliance
Perform IT and technology vendor qualification
Conduct supplier assessments and audits
Support computer system validation (CSV) activities
6. Inspection & Audit Readiness
Provide support for regulatory inspections
Ensure systems are inspection-ready
Maintain documentation compliance and traceability
7. SOPs & Regulatory Documentation
Provide input for SOPs, standards, and guidance documents
Perform regulatory gap assessments
Support health authority compliance requirements
8. CAPA & Remediation
Support CAPA development and execution
Review CAPA documentation
Assist with remediation activities and follow-ups
Minimum Requirements
Education & Experience
Bachelor’s degree with ~5 years experience
OR
Master’s degree with ~2 years experience
Core Experience Areas
Quality assurance and compliance in pharma/biotech environments
Audit and inspection management
Quality Management Systems (QMS)
GxP environments (GCP, GLP, GMP)
Technical Expertise
Computer System Validation (CSV)
Change control processes
IT supplier qualification and audits
Validation lifecycle management
Key Skills
Strong regulatory and compliance understanding
Attention to detail and documentation accuracy
Inspection readiness and audit support experience
Cross-functional collaboration
Risk-based quality thinking
Strong communication and escalation skills
Work Environment
Based in Hyderabad, India
Part of global Development Quality organization
Works with cross-functional R&D, IT, and compliance teams
Exposure to regulated systems and global quality frameworks
Company Overview
Novartis is a global healthcare leader focused on developing innovative medicines and ensuring high standards of quality, compliance, and patient safety across all stages of drug development.
Benefits & Culture
Strong focus on quality and patient safety
Global career development opportunities
Structured compliance and training frameworks
Inclusive and collaborative work environment
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