Director, Validation
HybridPhiladelphia, Pennsylvania, United States
Job Summary
Develop and execute the strategic roadmap for the laboratory validation program supporting research, translational medicine, manufacturing, and analytical development from clinical-stage through BLA submission. Establish governance and policies for equipment qualification (IQ/OQ/PQ), computerized systems validation (CSV), and inspection readiness across R&D and external vendors. Lead cross-functional teams in Quality Assurance, IT, and Regulatory Affairs to ensure data integrity compliance with FDA, EMA, and ICH guidelines. Build and mentor a high-performing validation organization while managing vendor deliverables and continuous improvement initiatives.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Computer Science, Pharmaceutical Sciences, or related discipline
- 12+ years of experience within biotechnology, pharmaceutical, cell therapy, gene therapy, or biologics industries
- Minimum 5 years leading validation organizations
- Demonstrated experience supporting BLA, NDA, or commercial biologics submissions
- Experience establishing validation programs in rapidly growing biotechnology organizations
- Experience supporting FDA inspections with positive outcomes
- Strong knowledge of laboratory operations supporting advanced therapies
- Extensive knowledge of Equipment Qualification (IQ/OQ/PQ)
- Extensive knowledge of Computerized Systems Validation
- Extensive knowledge of Risk-based Validation
- Extensive knowledge of GAMP 5
- Extensive knowledge of 21 CFR Parts 11, 210, 211, 600 series
- Extensive knowledge of 21 CFR Part 58 (where applicable)
- Extensive knowledge of ICH Q9
- Extensive knowledge of ICH Q10
- Extensive knowledge of FDA Data Integrity Guidance
- Extensive knowledge of EU GMP Annex 11
- Extensive knowledge of ALCOA+ principles
- Extensive knowledge of Validation lifecycle management
- Extensive knowledge of Laboratory automation
- Extensive knowledge of Analytical instrumentation
- Experience with Flow cytometry platforms
- Experience with Cell counting instruments
- Experience with PCR and qPCR systems
- Experience with Bioanalytical instrumentation
- Experience with Laboratory information systems
- Experience with Scientific software applications
Desired Qualifications
- Knowledge of autologous cell therapy manufacturing and analytical workflows
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