Manager, Quality Management Systems

Job description

Description: The Manager – Quality Management Systems & Compliance is responsible for end-to-end ownership of the Quality Management System (QMS) at an Oral Solid Dosage manufacturing site. This role ensures sustained compliance with global regulatory requirements (FDA, EMA, MHRA, ICH) and drives continuous improvement through robust risk management, and data-driven quality oversight. The position requires strong leadership in managing planned/unplanned deviations, CAPA, change controls, and audit readiness, while partnering cross-functionally to ensure product quality and regulatory compliance. The Manager, Quality Systems may also manage other quality assurance professional staff, and/or quality assurance programs and projects, and interfaces with both internal and external senior managers in operations and QA to ensure full compliance with FDA GMP standards and regulations. Influencing stakeholders and partners, and effectively recommending solution/options to complex quality assurance issues is required. Essential Functions: - Own and manage site QMS elements including Change Control, Deviations, CAPA, OOS, Complaints ensuring timely closure and compliance with cGMP - Lead and...