Director of Validation

Job Summary

Leading the laboratory validation program, the full-time Director of Validation will develop and implement strategies to ensure compliance with regulatory requirements while supporting Research, Translational Medicine, and Manufacturing functions, with the option for remote or hybrid work in Philadelphia, PA.

Key responsibilities

• Develop and execute the strategic roadmap for laboratory validation to support clinical-stage development through BLA submission and commercial launch
• Direct qualification activities for laboratory equipment and computerized systems, ensuring compliance with regulatory standards
• Lead inspection readiness activities and manage validation documentation for FDA pre-license inspections and regulatory audits

Required qualifications

• Bachelor's degree in Engineering, Life Sciences, Computer Science, Pharmaceutical Sciences, or related discipline
• 12+ years of experience in biotechnology, pharmaceutical, or biologics industries, with a minimum of 5 years in validation leadership
• Demonstrated experience supporting BLA, NDA, or commercial biologics submissions
• Strong knowledge of laboratory operations supporting advanced therapies and experience with FDA inspections
• Extensive knowledge of Equipment Qualification, Computerized Systems Validation, and regulatory compliance standards