Job Description Summary
#LI-Hybrid
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.
Job Description
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 diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Skills Desired
Applied Statistics, Leadership, Manufacturing Production, Manufacturing Technologies, Operational Excellence, Process Control, Quality Compliance, Regulatory Compliance, Technical Leadership, Technology Transfer