Director, Quality Systems

Role: Lead the internal Quality Systems team at Wave Life Sciences, focusing on GXP and GMP foundational processes such as document control, vendor management, and electronic Quality Management Systems (eQMS). Primary objectives include ensuring compliance, process improvement, and readiness for regulatory inspections as the company advances from investigational to commercial stages. Responsibilities encompass optimizing QMS processes, developing a high-performing QS team, maintaining regulatory compliance (FDA, EMA, ICH), and facilitating cross-functional collaborations for quality initiatives. Requirements: BS in a scientific discipline, 10-12+ years in pharmaceutical QA, 5+ years managing personnel, extensive experience with enterprise quality systems, vendor qualification, and GxP principles; strong leadership, communication, and change management skills. Preferred: Veeva experience, CSV and electronic system expertise, and familiarity with combination product regulations. High-Value: GMP and GXP focus, global regulatory compliance, Quality System development, and onsite presence at Lexington facility (4 days/week). The role involves strategic planning, process optimization, audit readiness, and fostering a culture of continuous improvement within a fast-paced biopharma environment.