Quality Management System Lead

Role: Senior Quality Assurance professional responsible for owning and enhancing the QMS framework to ensure compliance and document control across GxP domains (GMP/GLP/GCP) in a biotech setting. Responsibilities: define and maintain QMS policies, SOPs, templates; oversee document lifecycle management and change control; lead GxP training frameworks; ensure data integrity and audit readiness; establish metrics for QMS health; drive process simplification and CAPA initiatives; prepare management review packages. Requirements: Bachelor's in Life Sciences or related field; 8–12 years experience in QA or compliance within regulated GxP environments; hands-on QMS management expertise; experience with audits and inspections; strong understanding of data integrity, document control, and process governance; certifications such as ASQ or ISO Lead Auditor preferred. HighValue: biotech (cancer focus), GxP compliance, quality management, audits, process improvement; location Boston, onsite with no travel specified.