Technical Steward - Devices

About the role

Novartis is looking for a Technical Steward for Devices in Hyderabad, India, to provide 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. The role works with global suppliers, cross-functional partners and regulatory stakeholders, and leads a team of seven to eight specialists. Relocation support is not offered.

Key responsibilities

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

Required profile

• 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
• Experience managing external device suppliers, contract manufacturers and strategic partners across global markets
• Proven stakeholder and crisis management skills, including engagement with senior leaders and cross-functional teams
• Experience leading and developing a team, managing resources and ensuring quality delivery
• Fluency in English, with strong communication and data analysis skills

Required skills

• Strong knowledge of pharmaceutical manufacturing, GMP, quality risk management and global device regulations and standards
• Data analysis with Power BI, Tableau or similar tools
• Applied statistics, leadership, manufacturing production, operational excellence, process control, quality and regulatory compliance