eCompliance Manager

Job Description Summary

#LI-Hybrid
Location: Hyderabad, India
As an e Compliance Manager, you will make sure Novartis’ computerized systems are used in a way that is compliant, reliable, and inspection ready. Your focus will be on providing day to day quality oversight and clear guidance on computerized systems validation, working within regulatory requirements and Novartis quality standards. You will support project and operational teams by reviewing and approving GxP relevant changes, deviations, periodic reviews, and key validation deliverables, helping teams navigate compliance topics with confidence. Through close collaboration with information technology and business stakeholders, you will play a hands on role in keeping systems compliant throughout their lifecycle while supporting high quality, well controlled digital solutions.

 

Job Description

Key Responsibilities

• Provide quality oversight for day‑to‑day operations of regulated computerized systems

• Support compliance with Novartis quality standards and global regulatory requirements

• Act as the main quality contact for computerized systems validation topics

• Connect business and information technology teams on quality and compliance matters

• Review and approve project documents for regulated and non‑regulated computerized systems

• Build strong partnerships with information technology teams and support daily operations

• Review and approve regulated changes and required project deliverables

• Review and approve deviations and ensure corrective and preventive actions are implemented

• Support validation planning and execution for computerized systems across assigned functions

• Perform supplier qualification activities and support audits and inspections

Essential Requirements

• 10–15 years of overall information technology experience, including experiences in the pharmaceutical industry

• Strong experience in quality and compliance roles within regulated information technology environments

• Solid understanding of global regulatory expectations governing computerized systems

• Proven experience designing, implementing, and maintaining computerized systems across their full lifecycle

• Hands‑on experience supporting cloud‑based, software‑as‑a‑service, mobile, and digital solutions in regulated settings

• Strong operational experience managing regulated GxP systems and supporting technologies

• Good understanding of system application management, quality support models, and industry best practices

• Experience working across functions and geographies, including collaboration with complex international teams

Desirable Requirements

• Confidence presenting complex quality and compliance topics to senior management

• Strong stakeholder management skills, with the ability to influence, build trust, and create effective partnerships

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse team representative of the patients and communities we serve.

Accessibility and Accommodation

Novartis 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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

 

Skills Desired

Auditing, Audit Management, Audits Compliance, Communication, Continuous Learning, Decision Making, Gmp Procedures, Inspection Readiness, Managing Ambiguity, Organizing, People Management and Leadership, Qa (Quality Assurance), Regulatory Compliance, Risk Compliance (Inactive), Risk Management, Self-Awareness, Technical Knowledge