Director of Manufacturing Validation

Job Summary

A company is looking for a Director, Commercial Manufacturing Validation.

Key Responsibilities

• Contribute to validation strategies, programs, and continuous improvement initiatives
• Establish and maintain Validation Master Plans for all programs/projects
• Lead technical transfer activities and ensure compliant validation of manufacturing processes

Required Qualifications

• 10-15 years of relevant experience in the biotech or pharmaceutical industry (8-12 years with a Master's)
• Validation experience with multiple therapeutic modalities is required
• Familiarity with EMA and FDA validation requirements, including Lifecycle Model
• Lean Six Sigma training/certification is preferred
• Strong understanding of Good Manufacturing Practices (GMPs)