You will coach and develop a high-performing quality organization, ensure appropriate resourcing, represent site quality leadership in executive meetings, contribute to alignment with corporate quality strategy, and participate in strategic planning and facility expansion discussions. The role requires expert-level proficiency in cGMPs, 21 CFR Parts 210/211, ICH, and USP requirements, as well as demonstrated success leading FDA and customer audits, maintaining inspection readiness, and developing and verifying effective remediation plans.