Director, Quality Systems

Role: Director of Quality Systems at Wave Life Sciences, overseeing GXP foundational processes including document control, vendor management, and eQMS to ensure compliance from investigational stages to commercialization. Responsibilities: improve and streamline QMS processes, develop inspection readiness, lead cross-functional initiatives, oversee policy development, and manage internal/external audit preparations. Requirements: BS in a scientific discipline, 10-12 years in QA within the pharmaceutical industry, with at least 5 years managing personnel; extensive experience with enterprise quality systems, vendor qualification, and regulatory compliance (FDA, EMA, ICH); strong leadership, collaboration, and communication skills. Preferred: experience with CSV principles, Veeva, combination products, and GMP support in the biotech/pharma context. HighValue: focus on GMP compliance, quality process improvement, and regulatory readiness in a biotech setting supporting RNA-based therapies and clinical programs. Work setup: onsite in Lexington, 4 days/week.