Senior QMS Systems Lead (eQMS/eDMS)

Kiniksa Pharmaceuticals; Lexington (MA); Vor Ort; USD 186.000 - 200.000; Vollzeit

Zusammenfassung

Kiniksa Pharmaceuticals, based in Lexington, MA, seeks an Associate Director, Quality Management Systems (QMS) to lead the site’s GxP quality systems, including Documentation/Records and Deviations/CAPAs/Change Controls. This on-site role reports to the Director, QMS, and acts as the SME for eQMS and eDMS.

The role drives process improvements, ensures training compliance, and partners with IT to implement enhancements while maintaining strict regulatory alignment.

Qualifikationen

• Bachelor's degree in scientific or technical field and 8+ years of experience in Quality Systems within GxP-regulated environments.
• Hands-on experience as a business administrator for an eQMS and an eDMS (document control, deviations, CAPA, change control).
• Experience writing and maintaining Quality procedures.
• Knowledge of 21 CFR Part 11 and electronic records/signatures; related controls.

Aufgaben

• Administer deviation, CAPA, investigation, change control, andrecords processes in the eQMS.
• Lead weekly meetings to review open quality events and drive timely closure.
• Develop and implement Quality procedures for consistency and compliance.
• Provide training and first-line support; collaborate with IT on enhancements.
• Support inspection readiness activities and act as SME for document management and exceptions.

Kenntnisse

QMS administration

eQMS/eDMS admin

Inspection support

Project management

Cross-functional collaboration

Communication skills

Ausbildung

Bachelor's degree in scientific/technical field

Tools

Veeva Quality (QMS)

Microsoft Excel

Jobbeschreibung

Kiniksa Pharmaceuticals, based in Lexington, MA, seeks an Associate Director, Quality Management Systems (QMS) to lead the site’s GxP quality systems, including Documentation/Records and Deviations/CAPAs/Change Controls. This on-site role reports to the Director, QMS, and acts as the SME for eQMS and eDMS.

The role drives process improvements, ensures training compliance, and partners with IT to implement enhancements while maintaining strict regulatory alignment.