As the Site Head, you will be responsible for the overall management and performance of the OSD manufacturing facility, including production, quality, engineering, supply chain, regulatory compliance, and operational efficiency. You will work closely with senior leadership to align plant operations with business goals, strengthen quality systems, optimize costs, and ensure consistent delivery of products in compliance with global pharmaceutical standards.
The ideal candidate should currently be associated with a pharmaceutical manufacturing organization operating at a plant turnover level of approximately ₹250–500 crore and possess proven experience in managing large-scale OSD manufacturing operations and successfully handling regulatory inspections by USFDA and EU GMP authorities.
Requirements
Key Responsibilities
Lead the overall operations and strategic direction of the OSD manufacturing plant, ensuring achievement of production, quality, cost, and delivery targets.
Oversee end-to-end manufacturing operations, including production planning, formulation, packaging, engineering, maintenance, and supply chain coordination.
Ensure compliance with USFDA, EU GMP, and applicable pharmaceutical regulatory requirements.
Lead regulatory inspections and audits, ensuring continuous inspection readiness, effective audit responses, and timely closure of observations and corrective and preventive actions (CAPA).
Drive quality excellence, process improvements, deviation management, change control, and risk-based compliance practices across the facility.
Develop and implement operational strategies to improve productivity, capacity utilization, equipment effectiveness, and manufacturing efficiency.
Manage plant budgets, operating expenses, capital investments, and cost optimization initiatives.
Build, lead, and mentor cross-functional teams across manufacturing, quality, engineering, EHS, and support functions.
Collaborate with corporate leadership and other stakeholders to align plant performance with business objectives and growth plans.
Establish performance metrics and governance mechanisms to monitor operational excellence, quality compliance, and overall plant performance.
Promote a strong culture of safety, quality, accountability, continuous improvement, and regulatory compliance.
What Makes You a Great Fit?
Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Chemical Engineering, or a related discipline.
20+ years of experience in pharmaceutical manufacturing, with significant leadership experience in OSD operations.
Proven track record of leading and managing an Oral Solid Dosage manufacturing plant in a senior leadership capacity.
Strong hands-on experience in successfully handling USFDA and EU GMP audits and regulatory inspections.
Current or recent experience with a pharmaceutical manufacturing organization operating at a plant turnover level of approximately ₹250–500 crore.
Comprehensive understanding of pharmaceutical cGMP, quality management systems, regulatory compliance, and inspection readiness.
Demonstrated expertise in production planning, plant operations, capacity optimization, cost management, and operational excellence.
Experience managing large cross-functional teams and driving organizational performance in a regulated manufacturing environment.
Strong strategic thinking, financial acumen, decision-making, and stakeholder management capabilities.
Excellent leadership and communication skills, with the ability to drive quality culture, business growth, and continuous improvement across the plant.
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