Plant Head – IVD Manufacturing & Regulatory Operations Full Time

We are seeking an experienced and dynamic Plant Head to lead our In Vitro Diagnostics (IVD) manufacturing facility, possessing strong expertise in regulatory compliance, factory setup & commissioning, manufacturing operations and supply chain management within the medical devices/IVD industry. This leadership role will be responsible for establishing and scaling world-class manufacturing operations while ensuring compliance with global regulatory standards including WHO Prequalification, EU MDR, and CDSCO requirements.

Role Description

1) Regulatory & Compliance

• Lead regulatory compliance initiatives for IVD products across domestic and international markets.
• Drive implementation and maintenance of quality systems aligned with:
• EU MDR
• ISO 13485
• WHO Prequalification requirements
• CDSCO regulations
• Coordinate preparation, review, and submission of CDSCO dossiers and technical documentation.
• Liaise with regulatory authorities, notified bodies, auditors, and certification agencies.
• Ensure readiness for regulatory inspections and audits.

2) Factory Setup & Commissioning

• Lead end-to-end setup of manufacturing facility including:
• Plant layout planning
• Utility planning
• Equipment selection and qualification
• Cleanroom & DH room setup
• Validation and commissioning
• Establish manufacturing processes, SOPs, workflows, and operational controls.
• Coordinate with architects, consultants, EPC vendors, and engineering teams during project execution.
• Factory team building

3) Manufacturing Operations

• Oversee daily manufacturing operations to ensure quality, productivity, and compliance of Rapid Diagnostic Tests, Agglutination Tests and Molecular Biology QRTPCR Tests.
• Develop and implement production planning and capacity optimization strategies.
• Drive continuous improvement initiatives in productivity, efficiency, and cost reduction.
• Ensure adherence to GMP, EHS, and quality standards.
• Monitor KPIs related to production, rejection rates, downtime, and operational efficiency.

4) Supply Chain & Procurement

• Lead procurement, inventory management, logistics and vendor development activities.
• Develop supply chain strategies for raw materials, consumables and finished goods.
• Manage forecasting, material planning, and inventory optimization.
• Build relationships with domestic and international suppliers.

5) Leadership & Team Management

• Build & mentor cross-functional teams across production, quality, regulatory, warehouse and supply chain.
• Foster a culture of compliance, accountability, and operational excellence.
• Collaborate closely with R&D, QA/RA, finance, and commercial teams. 

Qualifications

• Master’s degree in Biotechnology, Microbiology, DMLT, Life Sciences, or related field.
• 5+ years of experience in IVD / Medical Device manufacturing operations.
• Proven experience in setting up and commissioning IVD manufacturing facilities.
• Strong working knowledge of:
• WHO Prequalification
• EU MDR
• CDSCO regulations
• ISO 13485
• GMP requirements
• Experience in CDSCO dossier preparation and regulatory submissions.
• Strong understanding of manufacturing systems, validation, and quality compliance.

·      Excellent leadership, project management, and problem-solving skills.

• Experience handling international regulatory audits.
• Exposure to automation and lean manufacturing practices.
• PMP / Six Sigma certification is an advantage. 

Key Competencies

• Strategic Leadership
• Regulatory Expertise
• Operational Excellence
• Project Management
• Supply Chain Optimization
• Cross-functional Collaboration
• Decision Making & Execution 

What We Offer

• Opportunity to lead a high-growth IVD manufacturing organization.
• Competitive compensation and performance incentives.
• Leadership role with strategic impact.
• Collaborative and innovation-driven work environment.