Manager, Quality Systems and Compliance

Job description

Job Description We are seeking a Manager, Quality Systems & Compliance to support the development and commercialization of innovative therapies by ensuring robust quality systems and regulatory compliance. This role plays a key part in managing core elements of the Quality Management System (QMS) and partnering cross-functionally to maintain compliance with global regulations (FDA, EMA, ICH, and other standards). The ideal candidate will bring strong GMP expertise and hands-on experience with quality systems, including Change Controls, Quality Events, and Annual Product Quality Reviews (APQRs). This individual will coordinate critical quality processes, drive operational efficiency, and support quality oversight across the organization. Key Responsibilities: - Lead Change Control processes, including intake, coordination of review boards, tracking, and reporting of key metrics - Manage Quality Event records (e.g., deviations), including tracking, reporting, and facilitating cross-functional review meetings - Coordinate and oversee the APQR process, ensuring timely review, approval, and documentation - Support Quality Management Review meetings, including scheduling, content develop...