Title:  General Manager - Production

Position: Head - Sterile Production

Designation: General Manager
Department: Sterile Manufacturing Operations
Location: Guwahati
Reports To: Cluster Head - SGO

Job Purpose

To provide strategic leadership and operational oversight for Sterile Production operations, ensuring safe, compliant, efficient, and cost-effective manufacturing of sterile pharmaceutical products. The role is responsible for delivering business objectives through flawless execution of manufacturing plans, maintaining global regulatory compliance, driving operational excellence, optimizing resources, and fostering a high-performance culture aligned with organizational values.

Key Responsibilities

Strategic Leadership & Manufacturing Excellence

• Lead end-to-end sterile manufacturing operations to achieve production targets in terms of Safety, Quality, Delivery, Cost, and Compliance.
• Develop and execute manufacturing strategies aligned with organizational goals and global regulatory expectations.
• Ensure uninterrupted supply of commercial products and successful introduction of new products within approved timelines.
• Drive continuous improvement initiatives to enhance productivity, efficiency, capacity utilization, and operational excellence.
• Establish long-term capacity planning strategies and identify opportunities for technology upgradation and automation.
• Maintain complete visibility of manufacturing activities from production planning through dispatch and product release support.

Quality, Compliance & Regulatory Oversight

• Ensure strict adherence to current Good Manufacturing Practices (cGMP), Data Integrity requirements, regulatory guidelines, and company quality standards.
• Maintain continuous state of inspection readiness for regulatory authorities
• Drive a culture of quality, compliance, and operational transparency across all manufacturing activities.
• Review and approve deviations, investigations, CAPAs, change controls, risk assessments, and other quality management system documents as authorized.
• Ensure timely investigation of manufacturing events, implementation of corrective and preventive actions, and dissemination of key learnings.
• Provide leadership during regulatory inspections, customer audits, and corporate quality assessments.

Operational Management

• Ensure effective planning, scheduling, and execution of sterile manufacturing operations to meet business commitments.
• Monitor manufacturing performance through defined KPI dashboards and MIS reports.
• Optimize utilization of manpower, equipment, utilities, and production facilities.
• Ensure timely mobilization of resources and resolution of operational constraints.
• Anticipate operational risks and proactively implement mitigation plans.
• Lead root-cause analysis and decision-making based on data, facts, business priorities, and risk assessments.

Cross-Functional Coordination

• Collaborate closely with Quality Assurance, Quality Control, Supply Chain, Regulatory Affairs, Engineering, Project Management, R&D, MSTG, Procurement, and Commercial functions.
• Ensure seamless information flow and coordinated decision-making across internal and external stakeholders.
• Facilitate effective interdepartmental interactions for issue resolution and execution of business priorities.
• Support technology transfer, validation, scale-up, and commercialization activities for new products.

Engineering, Projects & Technology

• Partner with Engineering and Project teams for facility upgrades, equipment procurement, automation initiatives, and installation of new manufacturing systems.
• Drive adoption of new technologies and digital manufacturing practices to improve operational performance.
• Ensure qualification and validation requirements are met for facilities, equipment, and manufacturing processes.
• Participate in strategic capital investment planning and execution.

People Leadership & Organizational Development

• Lead, coach, mentor, and develop production leadership teams and key technical personnel.
• Build a strong succession pipeline and organizational capability within sterile manufacturing functions.
• Establish a culture of accountability, ownership, collaboration, and continuous learning.
• Conduct performance reviews and talent development initiatives based on defined KPIs.
• Ensure availability of trained and qualified personnel to support current and future business needs.
• Delegate responsibilities appropriately to qualified deputies while maintaining overall accountability.

EHS & Risk Management

• Ensure compliance with all Environment, Health and Safety (EHS) requirements and company policies.
• Promote a strong safety culture and drive proactive risk identification and mitigation.
• Ensure adherence to contamination control strategies and aseptic manufacturing best practices.
• Lead business continuity and contingency planning for critical manufacturing operations.

Qualifications

Education

• Bachelor's or Master's Degree in Pharmacy, Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or related discipline.
• Advanced Management Qualification (MBA/Executive Leadership Program) preferred.

Experience

• 18-25+ years of pharmaceutical manufacturing experience.
• Minimum 10+ years of leadership experience in Sterile Manufacturing operations.
• Extensive experience managing aseptic manufacturing, injectables, ophthalmics, sterile dosage forms, or biologics manufacturing facilities.
• Demonstrated track record of successfully handling global regulatory inspections and audits.
• Experience in managing large teams and multi-functional manufacturing environments.
• Currently Working in Regulatory Site or previous experience of working in Regulatory sites

Technical Competencies

• Sterile Manufacturing Operations
• Aseptic Processing
• Contamination Control Strategy (CCS)
• Annex 1 Requirements
• cGMP and Data Integrity
• Validation & Qualification
• Regulatory Inspection Management
• Lean Manufacturing & Operational Excellence
• Project Management
• Technology Transfer
• Risk Management
• Capacity Planning
• Quality Systems
• Supply Chain Integration

Leadership Competencies

• Strategic Thinking
• Business Acumen
• Decision Making
• Change Leadership
• Stakeholder Management
• Coaching & Mentoring
• Problem Solving
• Influencing Skills
• Innovation Mindset
• Results Orientation
• Collaboration & Team Building