Role Overview:
We are looking for a seasoned and strategic leader to head the end-to-end operations of a EU-GMP regulated sterile injectable manufacturing facility (LVP/SVP). This role will be responsible for driving operational excellence, ensuring global regulatory compliance, and delivering consistent product quality while leading large cross-functional teams.
Key Responsibilities:
1. Plant Leadership:
- Lead complete plant operations including Production, QA/QC, Engineering, Warehouse, and HR
- Drive production targets, cost optimization, and operational efficiency
- Ensure alignment of plant operations with business objectives
2. Regulatory & Compliance:
- Ensure adherence to EU-GMP (mandatory), WHO-GMP, and USFDA standards
- Lead regulatory audits, inspections, and ensure continuous audit readiness
- Maintain high standards of compliance across all operational areas
3. Quality & Production Excellence:
- Oversee batch release processes, deviations, CAPA, validation, and compliance systems
- Drive continuous improvement initiatives in yield, productivity, and quality metrics
- Ensure zero compromise on product quality and compliance standards
4. Engineering & Projects:
- Ensure equipment reliability, utilities uptime, and robust maintenance systems
- Lead plant expansion, new projects, and technology upgrades
- Drive modernization initiatives for operational efficiency
5. Supply Chain Oversight:
- Manage inventory planning including RM/PM
- Ensure warehouse compliance and optimized supply chain operations
- Maintain efficient material flow to support uninterrupted production
6. Team Leadership:
- Build and lead high-performing cross-functional teams
- Drive a culture of accountability, performance, and safety
- Mentor and develop leadership pipeline within the organization
Skills & Qualifications:
Qualification: B.Pharm / M.Pharm
- 20-25 years of experience in pharma manufacturing
- Last 4-5 years in a leadership role
- Strong expertise in sterile injectables (LVP/SVP)
- Must have experience in EU-GMP regulated plant environment
- Exposure to EU / USFDA regulatory frameworks is mandatory
Special Requirements: Currently holding a role of Deputy Site Head / Plant Head (No.2 role) in a regulated injectable facility
Age: 45-53 years
- Strong leadership, stakeholder management, and decision-making capabilities
Closing Note:
This is a high-impact leadership opportunity for professionals looking to drive large-scale manufacturing operations in a globally regulated environment, with significant ownership across quality, compliance, and operational performance.
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