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Amneal Pharmaceuticals - Senior General Manager / Senior Manager - Product Delivery Development
AMNEAL PHARMACEUTICALS PRIVATE LIMITEDAhmedabad,Gujarat, India24 days ago
Job descriptionLead the design, validation, and lifecycle management of drug-device combination products, including auto-injectors, pen injectors, and inhalers. Ensure robust Design History Files (DHFs) and Design Control documentation per US FDA 21 CFR Parts 210 / 211 / 820, EU MDR, and ISO standards. Drive risk management frameworks (FMEA, Hazard Analysis, Fault Tree Analysis, LOPA) to ensure safety, compliance, and product robustness. Direct the development of URS, validation protocols, and V&V processes for manufacturing and functional test systems. Lead structured cross-functional reviews with R&D, Formulation, Operations, QA, RA, and Supply Chain to ensure seamless drug-device integration. Actively manage relationships with contract manufacturers, automation partners, and regulatory agencies. Influence global stakeholders, presenting technical and business-critical updates to leadership teams and steering committees. Mentor and coach engineering managers and design engineers, instilling a culture of accountability, technical excellence, and regulatory discipline. Establish best practices in design-for-manufacturing (DFM), design-for-assembly (DFA), and advanced risk assessment methodologies. Build and maintain high-performing teams capable of delivering complex medical device programs under accelerated timelines. Technical Mastery : Advanced expertise in GD&T, SolidWorks, injection molding, intricate mechanism design, DHF documentation, and V&V processes. Regulatory Rigor : Deep knowledge of FDA, EU MDR, ISO 13485, ISO 14971 and related medical device regulatory frameworks. Risk & Quality Leadership : Demonstrated authority in leading risk assessments, CAPA management, and quality-by-design initiatives. Executive Communication : Ability to influence senior executives and regulatory bodies through clear, concise, and authoritative communication. Change Leadership : Proven track record of driving organizational change, building scalable processes, and aligning cross-functional Bachelor's degree in Mechanical Engineering or related field (required). MBA from a top college is a plus Master's degree in Engineering Design, Medical Device Design, or related discipline Experience in medical device development (drug delivery preferred). Minimum 10 years of experience in the pharmaceutical / medical device industry. Minimum 5-7 years in people management / leadership roles, with demonstrated P&L and program delivery accountability.
Essential Functions :
The Senior Manager / Deputy General Manager will act as the technical and managerial owner of complex work streams within the development of parenteral and inhalation drug delivery systems, leading programs from concept design through to global commercialization. This leadership role requires end-to-end accountability for design control, regulatory compliance, cross-functional execution, and delivery of strategic business outcomes.
Core Responsibilities :
Leadership & Strategic Management :
- Provide vision, direction, and governance for all assigned device development projects, ensuring alignment with corporate objectives and regulatory strategy.
- Manage multi-disciplinary teams including internal staff, global partners, and contract resources across engineering, quality, regulatory, and operations.
- Define strategic priorities, budgets, and timelines, ensuring programs deliver on cost, quality, and schedule commitments.
- Act as the executive interface with internal senior leadership, regulatory bodies, and external manufacturing / automation vendors.
Program & Technical Ownership :
Cross-Functional Leadership :
Team Development & Capability Building :
Required Skills & Competencies :
(ref : iimjobs.com)
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General Manager • Ahmedabad,Gujarat, India
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