Director, Quality Inspection Management

Role: Lead inspection management and regulatory compliance for Celldex as it transitions to a commercial-stage biotech, ensuring readiness for FDA, EMA, MHRA, Health Canada inspections, partner audits, and launch activities. Responsibilities: develop and sustain inspection readiness programs across Quality, Manufacturing, Supply Chain, Regulatory, Clinical, and Commercial functions; oversee inspection responses and CAPA follow-ups; establish metrics for performance tracking; collaborate with CDMOs to prepare for inspections and address 'Hot Topics.' Qualifications: Bachelor's in Life Sciences, Pharmacy, Engineering, Chemistry, Microbiology, or related; 10+ years in GMP Quality Assurance, Regulatory Inspection Management, or related fields within biotech/pharma; proven experience leading FDA and international inspections; experience with biologics, monoclonal antibodies, sterile products, or advanced therapeutics; familiarity with clinical and commercial stages, supply networks, and post-approval operations. HighValue: biologics, monoclonal antibodies, sterile products; biologics development; GMP compliance; global regulatory inspections; clinical to commercial transition. WorkSetup: Not specified; focus on cross-functional and global coordination.