Associate Director Quality at Sharp Corporation

The Associate Director of Quality provides strategic and operational leadership for a pharmaceutical site’s Quality Assurance, Quality Systems, Compliance, and Validation functions. The role oversees quality systems, regulatory compliance, risk management, inspection readiness, customer engagements, quality events, and continuous improvement; serves as the primary quality representative during regulatory and customer activities; and directly supervises the entire quality organization. The position requires knowledge of FDA cGMP/GCP, EMA, ICH, 21 CFR Part 11, DEA regulations, and pharmaceutical industry practices, along with team management, cross-functional change, communication, and problem-solving skills.