Technical Steward - Devices

Novartis India; Hyderabad; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Novartis India seeks a Technical Steward - Devices to lead medical device integration across drug-delivery systems. Based in Hyderabad, you will guide late-stage development through lifecycle management with global partners, ensuring device compliance and reliable product delivery.

The role requires a strong pharmacovigilance mindset, GMP knowledge, and proven team leadership to drive cross-functional initiatives across regions.

Qualifications

• Degree in Pharmacy, Pharmaceutical Sciences, Engineering, or a related technical discipline.
• 10–12 years in pharma with medical devices or drug–device products.
• Experience managing external device suppliers and partners globally.
• Strong stakeholder and crisis management skills with senior leaders.
• Knowledge of GMP, quality risk management and device regulations.

Responsibilities

• Serve as device expert for high-priority brands across their life-cycle.
• Assess device-drug compatibility, performance, quality and patient-use risks.
• Review supplier documentation to confirm device performance and regulatory readiness.
• Lead late-stage development, tech transfer, scale-up, and lifecycle maintenance.
• Prepare and maintain device documentation including DHF, risk, and human factors files.
• Coordinate with suppliers, manufacturing, quality and regulatory teams to resolve issues.
• Maintain inspection readiness and support audits/regulatory inspections.
• Lead a team of seven to eight specialists, setting priorities and ensuring timely delivery.

Skills

Leadership

Stakeholder management

Crisis management

Team leadership

Data analysis

Education

Pharmacy/Pharmaceutical Sciences/Engineering degree

Tools

Power BI

Tableau

Job description

Summary

Location: Hyderabad, India

Relocation Support: This role is based in Hyderabad, India. Novartis is unable to offer relocation support: please only apply if accessible.

What happens when cutting-edge medicines meet equally innovative device technology? Patients receive treatments that can transform lives. As Technical Steward - Devices, you will be at the center of that intersection, providing technical leadership for medical devices and drug-device combination products throughout their lifecycle. From late-stage development and technology transfer to commercialization, lifecycle management, and product retirement, you will ensure that device technologies are fit for purpose, compliant, and capable of supporting reliable product delivery. Working with global suppliers, cross-functional partners, and regulatory stakeholders, you will serve as a trusted device expert, lead strategic product activities, and manage a team of specialists dedicated to advancing some of Novartis' most important therapies.

About The Role

Key Responsibilities

• Serve as the device expert for high-priority brands, overseeing auto-injectors and other drug-delivery systems throughout their life-cycle.
• Assess how device technologies operate with drug products, identifying compatibility, performance, quality, and patient-use risks.
• Review supplier documentation and technical data to confirm devices perform as intended and meet health authority requirements.
• Lead technical activities from late-stage development and technology transfer through scale-up, commercialization, life-cycle maintenance, and product retirement.
• Prepare and maintain device documentation, including design history, risk management, human factors, and post-market surveillance files.
• Respond to health authority questions and provide technical input for regulatory submissions involving devices and combination products.
• Investigate device-related quality issues, evaluate proposed changes, and recommend actions that protect product quality and reliable delivery.
• Work with suppliers, development teams, manufacturing sites, quality, and regulatory partners to resolve technical challenges and transfer knowledge.
• Maintain inspection readiness by reviewing technical records and providing device expertise during audits and regulatory inspections.
• Lead and develop a team of seven to eight specialists, setting priorities and ensuring high-quality, timely delivery.

Essential Requirements

• Degree in Pharmacy, Pharmaceutical Sciences, Engineering, or another relevant scientific or technical discipline.
• At least 10 to 12 years of pharmaceutical industry experience, including medical devices or drug-device combination products.
• Strong understanding of drug products, device technologies, and their compatibility within injectable drug-delivery systems.
• Demonstrated experience managing external device suppliers, contract manufacturers, and strategic partners across global markets.
• Proven stakeholder and crisis management skills, including regular engagement with senior leaders and cross-functional teams.
• Experience leading and developing a team, setting priorities, managing resources, and ensuring high-quality delivery.
• Strong knowledge of pharmaceutical manufacturing, Good Manufacturing Practice, quality risk management, and global device regulations and standards.
• Fluency in English, with strong communication and data analysis skills, including interpreting large datasets using Power BI, Tableau, or similar tools.

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 [e-mail] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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.

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