Specialist, Quality Operations

Novartis AG; Hyderabad; Hybrid; INR 1,800,000 - 2,600,000; Full time

Job summary

Novartis AG seeks a Specialist, Quality Operations in Hyderabad, India to manage Change Controls and ensure GxP conformity within the Quality Management System. You will support audits, KPI reporting, and document creation across SOPs, investigations, and trend reports.

The role requires a Master’s degree in science or engineering and at least 6 years of experience in QA, regulatory affairs, pharma manufacturing, or medical devices. Hybrid work arrangement in Hyderabad is available.

Qualifications

• Master’s degree in Science, Engineering, or equivalent.
• Minimum of 6 years’ experience in Quality Assurance, Regulatory Affairs, Pharmaceutical Manufacturing, or Medical Devices.
• Stakeholder management and project coordination.
• Knowledge of change control and quality systems.
• Data analysis and reporting capabilities.
• Proficiency in enterprise digital tools and MS Office.
• Basic understanding of GxP requirements.

Responsibilities

• Manage Change Controls from initiation through closure using approved Novartis systems.
• Ensure timely, accurate, and compliant execution of assigned activities.
• Support KPI reporting, governance activities, and business process requirements.
• Create and review GxP documents, SOPs, trend reports, qualification reports, and investigations as required.
• Support internal and external audits by providing process documentation, data, and reports.
• Escalate GxP and non-GxP issues and support investigation activities.
• Generate and analyze reports and follow up on actions arising from quality processes.
• Perform designated roles such as CRB Facilitator, Entity Data Manager, Business Approver as needed.
• Maintain compliance with Novartis quality standards, regulatory requirements, and operating procedures.

Skills

Stakeholder management

Project coordination

Data analysis and reporting

Quality systems

GxP knowledge

Education

Master’s degree in Science, Engineering, or equivalent

Tools

MS Office

Job description

# Specialist, Quality OperationsREQ-10085872Sep 16, 2026India### Summary#LI-Hybrid Location: Hyderabad, India This role is based in Hyderabad, India. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. The Specialist, Quality Operations manages Quality aspects and projects within area of responsibility. Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.### About the Role**Major Accountabilities:*** Manage Change Controls from initiation through closure using approved Novartis systems.* Ensure timely, accurate, and compliant execution of assigned activities.* Support KPI reporting, governance activities, and business process requirements.* Create and review GxP documents, SOPs, trend reports, qualification reports, and investigations as required* Support internal and external audits by providing process documentation, data, and reports.* Escalate GxP and non-GxP issues and support investigation activities.* Generate and analyze reports and follow up on actions arising from quality processes.* Perform designated roles such as CRB Facilitator, Entity Data Manager, Business Approver as per business needs,* Maintain compliance with Novartis quality standards, regulatory requirements, and operating procedures.**Required Competencies*** Master’s degree in Science, Engineering, or an equivalent qualification* Minimum of 6 years’ experience in Quality Assurance, Regulatory Affairs, Pharmaceutical Manufacturing, or Medical Devices* Stakeholder management and Project coordination* Knowledge of change control and quality systems* Data analysis and reporting capabilities* Proficiency in enterprise digital tools and MS Office applications* Basic understanding of GxP requirements**Why Novartis:** Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture **You’ll receive**: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards **Commitment to Diversity and Inclusion:** Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.**Why Novartis:** Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture**Benefits and Rewards:** Learn about all the ways we’ll help you thrive personally and professionally. Read our handbook (PDF 30 MB)OperationsOtherIndiaHyderabad (Office)IN10 (FCRS = IN010) Novartis Healthcare Private LimitedQualityFull timeRegularNo### Accessibility and accommodationNovartis 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 [e-mail] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.