Director CMC Quality Compliance (Hybrid)

Role: Lead inspection readiness and compliance for global GMP sites, including internal manufacturing and external CMOs, ensuring risk-based, phase-appropriate quality standards. Responsibilities: develop and monitor inspection management programs, interpret and incorporate evolving cGMP regulations, identify compliance risks, and implement improvement action plans. Provide strategic guidance and leadership across quality functions, fostering a strong quality culture and integrating new modalities into quality systems. Requirements: Bachelor's degree in a scientific or health-related field; 10+ years of experience in GxP quality, with at least 3 years in a managerial role; expert knowledge of GMP regulations, inspection management, risk assessment, and quality governance. Preferred: experience across multiple GxP areas, proven leadership in inspection readiness, and strategic influence skills. High-Value: extensive GMP regulatory expertise, focus on inspection preparedness, and leadership in a biopharma manufacturing environment. WorkSetup: hybrid or on-site; travel up to 10%.