Head of Manufacturing operations (medical device)

Menschen Consulting Pvt. Ltd. · Remote, India

1. Job Purpose

The Head – Manufacturing will be responsible for leading the overall manufacturing and operations function of the IVD business, ensuring capacity, quality, cost, productivity, regulatory compliance, supply reliability and operational excellence .

The role will oversee end-to-end manufacturing operations covering raw-material planning, production, formulation, filling, packaging, quality systems, engineering, maintenance, warehouse, supply chain and plant operations , while ensuring compliance with applicable IVD/medical-device regulatory requirements.

The Head –will work closely with the CEO/MD, R&D, Quality, Regulatory, Sales & Marketing, Finance and Supply Chain teams to scale the organization and build a high-quality, cost-efficient and globally compliant manufacturing operation .

2. Key Responsibilities

A. Manufacturing & Plant Operations

• Lead overall manufacturing operations for medical device /IVD reagents, kits, calibrators, controls and diagnostic products.
• Drive production planning and execution in line with business demand and sales forecasts.
• Ensure achievement of production targets, OTIF delivery, yield and productivity.
• Develop manufacturing capacity plans for current and future business requirements.
• Optimize manpower, machines, production lines and facility utilization.
• Establish standardized manufacturing processes and SOPs.
• Drive reduction in production cycle time, rejection, wastage and batch failures.
• Ensure robust batch manufacturing, filling, labeling and packaging processes.
• Develop scalable manufacturing systems for new product launches.

B. Quality & Regulatory Compliance

• Ensure manufacturing operations comply with applicable IVD, medical-device, GMP and quality-system requirements .
• Work closely with QA/QC and Regulatory Affairs to maintain audit readiness.
• Ensure effective implementation of SOPs, CAPA, deviation, change control and batch-release systems.
• Drive compliance with applicable standards such as ISO 13485 and relevant Indian/international IVD regulatory requirements.
• Ensure traceability of raw materials, components, batches and finished products.
• Establish a strong quality culture across manufacturing operations.
• Support regulatory inspections and customer audits.

C. Production Excellence

• Establish and monitor KPIs for production efficiency.
• Drive Lean Manufacturing, Six Sigma, Kaizen, 5S and TPM initiatives.
• Improve OEE, yield, throughput and first-pass quality.
• Reduce batch-to-batch variation.
• Identify bottlenecks and implement corrective actions.
• Develop visual management and daily production review systems.
• Drive continuous improvement across manufacturing processes.

D. Supply Chain & Procurement

• Work closely with Procurement and Supply Chain teams to ensure uninterrupted availability of critical medical device /IVD raw materials.
• Develop strategic sourcing plans for critical biological, chemical and packaging materials.
• Ensure appropriate inventory levels for critical raw materials and finished goods.
• Identify alternate sources and mitigate supply-chain risks.
• Improve inventory turns and reduce obsolete/slow-moving inventory.
• Collaborate with Purchase for vendor qualification and development.

E. R&D / New Product Transfer

• Work closely with R&D for new product commercialization and technology transfer .
• Establish robust scale-up and manufacturing processes for new IVD products.
• Ensure successful transfer from laboratory/pilot scale to commercial manufacturing.
• Participate in process validation and equipment/facility qualification.
• Ensure manufacturability, cost optimization and scalability of new products.
• Support launch planning and commercialization timelines.

F. Engineering & Maintenance

• Ensure high availability and reliability of manufacturing equipment.
• Develop preventive and predictive maintenance systems.
• Oversee utilities, HVAC, cleanrooms, water systems and critical manufacturing infrastructure.
• Drive automation and digitization of manufacturing processes.
• Evaluate and implement new technologies to improve productivity and quality.
• Develop CAPEX plans based on business growth and capacity requirements.

G. Cost & P&L Management

• Take ownership of manufacturing cost and operational efficiency.
• Drive reduction in conversion cost and manufacturing overheads.
• Optimize manpower and resource utilization.
• Prepare and manage annual manufacturing budgets and CAPEX.
• Monitor cost per batch/unit and identify cost-reduction opportunities.
• Support overall business profitability and EBITDA improvement.

H. People & Leadership

• Build and lead a high-performance manufacturing organization.
• Develop Plant Heads, Production Heads, Quality, Engineering and Supply Chain leaders.
• Establish clear KRAs, KPIs and performance-management systems.
• Develop technical and leadership capabilities within the operations team.
• Build a culture of accountability, quality and continuous improvement.
• Ensure succession planning for critical operational positions.

4. Candidate Profile

The ideal candidate should have:

• 18–25+ years of experience in manufacturing/operations.
• Strong experience in IVD, diagnostics, medical devices, biotechnology, life sciences, pharma, reagents or related regulated manufacturing .
• Experience managing large-scale manufacturing operations and multiple functions.
• Strong understanding of quality and regulatory systems.
• Proven experience in capacity expansion, plant setup, automation and operational excellence .
• Experience in new product scale-up and technology transfer.
• Strong commercial and financial understanding.
• Experience managing cross-functional teams and senior stakeholders.
• Strong exposure to international customers/audits would be preferred.