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Quality Manager (Ecompliance)

Novartis
2+ years
Not Disclosed
Hyderabad
9 May 26, 2026
Job Description
Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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