Agile Consulting Services

Job Description Position: Senior Vice President / Chief Operating Officer (COO) Industry: API / Pharmaceutical Manufacturing Location: Karnataka Role Overview The Senior Vice President / Chief Operating Officer (COO) will provide strategic and operational leadership for end-to-end API manufacturing operations, ensuring excellence in compliance, quality, cost, delivery, safety, and sustainability. The role is critical in driving regulatory-compliant growth, operational efficiency, and capacity expansion while meeting stringent global regulatory standards such as USFDA, EU-GMP, WHO-GMP, and other international norms. The incumbent will work closely with the Managing Director / CEO and Board to translate business strategy into robust operational execution across multi-plant API manufacturing facilities. Key Responsibilities Strategic & Business Leadership Partner with MD/CEO to define and execute operational strategies aligned with business growth, regulatory requirements, and global market expansion. Lead capacity expansion, debottlenecking, brownfield and greenfield API manufacturing projects. Drive digitalization, automation, data integrity, and Industry 4.0 initiatives across manufacturing operations. API Manufacturing Operations Oversee end-to-end API manufacturing including production, maintenance, utilities, engineering, and process optimization. Ensure consistent achievement of production targets with optimal cost, yield, and cycle time. Drive process improvements, scale-up, tech transfer, and validation activities in coordination with R&D and QA teams. Quality & Regulatory Compliance Ensure strict compliance with cGMP, data integrity, and regulatory guidelines (USFDA, EU-GMP, PMDA, TGA, etc.). Lead and manage regulatory inspections, audits, and customer audits with zero critical observations. Strengthen quality systems including deviations, CAPA, change management, risk assessments, and validation. Supply Chain & Planning Provide leadership to procurement, vendor development, materials management, and logistics functions. Ensure uninterrupted supply of key raw materials, solvents, intermediates, and utilities. Drive robust S&OP processes to align demand forecasts with production and capacity planning. Financial & Cost Management Own operational budgets, cost controls, and EBITDA improvement initiatives. Drive yield improvement, solvent recovery, energy optimization, and waste reduction programs. Track and present key operational and compliance KPIs to the Board. EHS & Sustainability Champion EHS excellence with a zero-incident culture across all manufacturing sites. Ensure compliance with environmental regulations, effluent treatment, hazardous waste management, and sustainability goals. Drive ESG initiatives and continuous improvement in environmental performance. People Leadership & Culture Build and mentor strong leadership teams across manufacturing, QA, QC, Engineering, EHS, and Supply Chain. Drive talent development, succession planning, and leadership capability building. Foster a culture of compliance, accountability, continuous improvement, and operational excellence. Key Skills & Competencies Deep expertise in API manufacturing and regulatory environments Strong understanding of cGMP, data integrity, and global regulatory expectations Strategic mindset with strong execution capability Financial acumen with cost and margin focus Change management and transformation leadership Excellent stakeholder and regulator-facing communication skills Qualifications & Experience Bachelors degree in Chemical Engineering / Pharmaceutical Sciences or related discipline; MBA preferred. 22–30 years of progressive experience in API / pharmaceutical manufacturing. Minimum 8–10 years in senior leadership roles such as Plant Head, Operations Head, VP Operations, or COO. Proven experience handling multiple successful USFDA / EU-GMP inspections. Experience in managing multi-site API operations preferred. Reporting Structure Reports to: Managing Director / CEO Direct Reports: Plant Heads, Manufacturing, QA, QC, Engineering, EHS, Supply Chain Key Performance Indicators (KPIs) Regulatory compliance and audit outcomes Production efficiency, yield, and cost metrics Safety and environmental performance On-time delivery and customer satisfaction Operational profitability and EBITDA Leadership effectiveness and talent development This position is for one of the leading API manufacturers based in Karnataka.