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.
