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.