Senior Vice President / Chief Operating Officer : Leading API Company

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.