Assoc. Director, Quality Management Systems

Kiniksa Pharmaceuticals seeks an Associate Director of Quality Management Systems to oversee GxP quality systems, including document control, records management, and exception handling. This Lexington, MA-based role requires on-site presence five days per week and serves as the primary administrator and subject matter expert for electronic quality systems.

Responsibilities

• Administer deviation, CAPA, investigation, complaint, and change control processes within eQMS
• Serve as business administrator and subject matter expert for eQMS and eDMS platforms
• Lead weekly quality event review meetings and track closure progress
• Develop and implement quality procedures ensuring regulatory compliance
• Produce, trend, and publish quality metrics for management review

Requirements

• Experience administering quality management systems and electronic document management platforms
• Knowledge of GxP regulations, deviations, CAPAs, change controls, and investigations
• Demonstrated ability to lead process improvements and manage quality metrics
• User support and training experience with software systems
• Strong written and verbal communication skills
• Experience with records management, retention, and compliance documentation