Associate Director, Validation

Role: Associate Director of Validation leading qualification and validation teams at a biopharma site, with responsibilities spanning system validation, regulatory compliance, and operational leadership. Key duties include managing validation documentation for laboratory instruments and systems per ISPE GAMP 5, 21CFR Part11, and FDA guidelines; driving performance and strategic planning; ensuring resource adequacy; representing validation during GMP and regulatory inspections; leading continuous improvement projects; and managing validation budget. Qualifications: Bachelor's in Life Sciences or Engineering; 10+ years in biopharma or related fields with 5+ years in leadership; expertise in GxPs, GAMP, CFRs, Data Integrity, and validation lifecycle; experience with calibration software, electronic document systems, and technical documentation. HighValue: extensive validation experience in biologics or laboratory systems, regulatory compliance focus, data integrity, and GMP oversight. Collaboration: cross-functionally with QA, Manufacturing, and regulatory teams. Worksetup: not specified; likely on-site or hybrid given leadership and validation scope.