Sr. GM- Operations (Injectable Site)

Position Overview

The Site Operations Head will lead end-to-end operations for an injectable manufacturing facility ensuring compliance with regulatory standards operational efficiency and delivery of high-quality sterile products. This role requires strong leadership technical expertise in aseptic manufacturing and the ability to drive cross-functional collaboration across production quality engineering and supply chain.

Key Responsibilities

• Operational Leadership

  • Oversee daily site operations including production engineering quality and supply chain functions.
  • Ensure smooth execution of manufacturing schedules to meet business and customer requirements.
  • Drive continuous improvement initiatives for productivity cost optimization and risk mitigation.

• Compliance & Quality

  • Ensure adherence to cGMP USFDA EMA and other global regulatory guidelines for sterile injectables.
  • Partner with Quality Assurance to maintain highest standards of product safety and compliance.
  • Lead site audits regulatory inspections and implement corrective/preventive actions.

• Strategic Management

  • Develop and execute site operational strategies aligned with corporate goals.
  • Manage budgets resource allocation and capital expenditure planning.
  • Build resilience in supply chain and vendor management for uninterrupted operations.

• People Leadership

  • Lead mentor and develop cross-functional teams to build a culture of accountability and excellence.
  • Drive training programs for aseptic techniques safety and compliance.
  • Foster collaboration between site teams and corporate stakeholders.

• Safety & Sustainability

  • Ensure workplace safety standards and EHS compliance.
  • Promote sustainable practices in energy waste management and resource utilization.

Qualifications & Experience

• Bachelor’s/Master’s degree in Pharmacy Biotechnology Chemical Engineering or related field.
• 20 years of experience in pharmaceutical manufacturing with at least 7 years in sterile injectable operations.
• Proven track record of leading large-scale manufacturing sites with regulatory approvals (USFDA EMA WHO).
• Strong knowledge of aseptic processing lyophilization and sterile filling technologies.
• Excellent leadership communication and stakeholder management skills.

Competencies

• Strategic thinking with operational execution capability.
• Strong compliance orientation and risk management.
• Ability to lead change and drive continuous improvement.
• High integrity and commitment to quality and safety.