Deputy Manager / Manager - Operational Excellence (Injectables)

Job Purpose

To drive a robust culture of continuous improvement, strategic operational excellence, and process optimization across Injectable/Sterile Manufacturing Operations. This role enhances productivity, quality, compliance (cGMP), and cost-efficiency while ensuring strict adherence to aseptic processing standards and global regulatory expectations.

Key Responsibilities

• Develop, deploy, and execute the site-wide Operational Excellence (OpEx) roadmap, ensuring alignment with annual business goals and strategic productivity targets.
• Lead Lean, Six Sigma, and Kaizen initiatives to improve productivity, reduce waste, and optimize cycle times in sterile manufacturing.
• Facilitate value stream mapping (VSM) for injectable processes including compounding, filling, lyophilization, inspection, and packaging.
• Drive right-first-time (RFT), OEE improvement, and deviation reduction initiatives.
• Ensure all improvement activities comply with cGMP, data integrity, and aseptic processing requirements.
• Prioritize cost savings and compliance / yield improvement
• Support regulatory inspection readiness (FDA, EMA,WHO, MHRA, etc.) through robust processes and documentation.
• Partner with Quality Assurance to ensure changes follow change control and risk management (ICH Q9).
• Use data analytics and statistical tools to identify trends, root causes, and improvement opportunities.
• Work closely with Manufacturing, Quality, Engineering, Supply Chain, and EHS teams.
• Coach and mentor team members on OpEx tools and continuous improvement culture.
• Conduct training sessions on Lean, Six Sigma, 5S, Standard Work, and Visual Management.

Qualifications, Experience & Skills

• Bachelors degree in Pharmacy, Chemical Engineering, Mechanical Engineering and Masters degree or MBA is an advantage. 12+ years of experience in pharmaceutical manufacturing, with strong exposure to injectable/sterile operations.
• Proven experience leading Operational Excellence or Continuous Improvement programs in a GMP environment.
• Hands-on experience with Lean, Six Sigma, and change management initiatives.
• Deep understanding of injectable manufacturing processes and aseptic operations
• Strong knowledge of cGMP, regulatory expectations, and data integrity
• Expert proficiency in MS Office (advanced Excel and PowerPoint) combined with hands-on experience building interactive Power BI dashboards and leveraging AI-driven predictive analytics to track real-time manufacturing KPIs, automate reporting, and minimize process variability.