• 12–18 years of manufacturing operations experience within Medical Devices, Pharmaceuticals, Biologics, or regulated healthcare manufacturing.
• Significant experience leading assembly and packaging operations.
• Proven experience managing high-performing manufacturing teams in a cGMP-regulated environment.
• Demonstrated success in regulatory inspections and quality systems.
• Strong background in Lean Manufacturing, Operational Excellence, and Continuous Improvement.
Education
• Bachelor's degree in engineering.
• Master's degree preferred.
Key Responsibilities
Manufacturing Operations Leadership
• Lead end-to-end assembly and packaging operations for medical devices, ensuring safe, compliant, and effective manufacturing.
• Own daily manufacturing performance with complete accountability for delivery commitments, quality, productivity, and cost.
• Drive production planning and execution to ensure optimum utilization of manpower, equipment, materials, and manufacturing capacity.
• Ensure quarterly business deliverables and operational KPIs are consistently achieved.
Delivery Excellence & Operational Ownership
• Take complete ownership for manufacturing schedules and customer delivery commitments.
• Establish and monitor operational KPIs including:
o On-Time Delivery
o Schedule Adherence
o Overall Equipment Effectiveness (OEE)
o Productivity
o First Pass Yield
o Right First Time
o Packaging Efficiency
o Training Compliance
o Quality Metrics
• Proactively identify operational risks and implement mitigation plans to ensure uninterrupted supply.
Quality, Compliance & GMP Leadership
• Champion a strong quality culture through strict adherence to cGMP, GDP, SOPs, and regulatory requirements.
• Ensure all manufacturing documentation is accurate, complete, and inspection-ready.
• Maintain continuous audit preparedness for internal, customer, and global regulatory inspections.
• Ensure compliance with applicable medical device quality standards and regul
📌 Medical Device (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru
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