Continuous Improvement Lead - Vaccine Manufacturing (DS&DP

Continuous Improvement Lead (CI) - VDSP, Lalru & VDPP, Baddi

Reports To

Department

Job Location:

Role Summary:

To lead and institutionalize continuous improvement (CI) initiatives across the WHO prequalified vaccine manufacturing facility by driving cost reduction, waste elimination, energy optimization,yield improvement and process excellence. The role promotes a culture of innovation, quality initiatives and operational efficiency aligned with cGMP, WHO, and other global regulatory standards.

Key Responsibilities:

1. Continuous Improvement & Operational Excellence

• Identify and execute improvement projects focused on yield improvement, cycle time reduction, cost savings, and resource optimization.
• Promote Lean, Six Sigma, and Kaizen practices across all manufacturing and support functions.
• Drive initiatives such as 5S, Visual Management, TPM, to enhance efficiency and reduce variability.
• Implement SPC(Statistical Process Control0 and SQC ( Statistical Quality Control)

2. Regulatory Compliance & GMP Alignment

• Ensure CI initiatives are aligned with WHO, USFDA, EU-GMP, and cGMP requirements.
• Support validation and qualification teams in improving process robustness and data integrity.
• Collaborate with QA, QC, and Regulatory Affairs to maintain compliance while improving systems and procedures.
• Work closely with manufacturing, QA, QC, RA, Engineering & SCM heads to identify bottle necks and area for improvement.
• Partner with functional leaders to standardize processes and reduce variation across plants or departments
• Facility CI project governance, tracking, reporting & escalation to COO

3. CI Project Leadership & Execution

• Lead cross-functional CI projects across Drug Substance Plant , Drug Product, Formulation, Filling, and Packaging areas.
• Develop project charters, timelines, and ROI analysis; track benefits and report to leadership.
• Facilitate Kaizen events and root cause investigations (using 5 Whys, Fishbone, FMEA, etc.).

4. Capability Building & Cultural Transformation

• Train employees at all levels in Lean principles, Six Sigma tools, and structured problem-solving.
• Build CI mind-set across production, quality, engineering, and warehouse teams.
• Conduct Gemba walks, performance huddles, and innovation forums to engage teams.

5. Performance Monitoring & Reporting

• Establish CI metrics and dashboards (OEE, Waste %, Yield, Downtime, etc.) and monitor regularly.
• Track CAPA effectiveness, deviation trends, and quality improvements as part of the CI program.

Qualifications & Experience:

• Bachelors or Master’s degree in Engineering, Pharmacy, Biotechnology, or Life Sciences.
• Certified Lean Six Sigma Green Belt or Black Belt (preferred).
• Minimum 6–10 years of demonstrated relevant experience in vaccine/biotech/pharma manufacturing, preferably in a WHO-GMP or global regulatory-compliant facility.

Key Skills & Competencies:

• Strong understanding of GMP, WHO, and global vaccine manufacturing regulations
• Proven expertise in Lean, Six Sigma, and Kaizen tools
• Analytical, data-driven decision-making
• Strong facilitation, coaching, and change management skills
• Cross-functional leadership and collaboration abilities
• Proficiency in using CI tools/software (e.g., Minitab, Power BI, etc.)