Director of Manufacturing Validation

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)