Associate Director, QMS & eQMS Excellence

Regulatory Jobs; Lexington (MA); On-site; USD 186,000 - 200,000; Full time

Job summary

Kiniksa Pharmaceuticals is seeking an Associate Director, Quality Management Systems (QMS) to lead GxP quality systems at the Lexington, MA site. This onsite role focuses on eQMS/eDMS administration, deviations, CAPAs, change controls, and investigations, with a mandate to drive process improvements and regulatory readiness.

The candidate will manage training, provide system support, and collaborate with QA, IT, and regulatory teams.

Qualifications

• Bachelor's degree in a scientific or technical field and 8+ years in Quality Systems within a GxP environment.
• Hands-on eQMS/eDMS administration experience and knowledge of 21 CFR Part 11.
• Experience writing Quality procedures and presenting metrics to leadership.

Responsibilities

• Administer the eQMS and eDMS, including user access, deviations, CAPAs, change controls, and investigations.
• Lead weekly quality meetings and drive timely closure of events and activities.
• Develop and implement quality procedures ensuring consistency and regulatory compliance.
• Promote system capabilities across the organization and train users.
• Support inspection readiness and interact with regulatory inspectors as needed.
• Produce and trend quality metrics for leadership review.

Skills

eQMS administrator

eDMS administrator

GxP knowledge

ICH guidelines

Quality metrics

Cross-functional leadership

Regulatory inspections support

Veeva Quality applications

Microsoft Excel

Project management

Education

Bachelor's degree in scientific or technical field

Tools

Veeva Quality (QMS/QualityDocs)

Microsoft Office (Excel)

Job description

Kiniksa Pharmaceuticals is seeking an Associate Director, Quality Management Systems (QMS) to lead GxP quality systems at the Lexington, MA site. This onsite role focuses on eQMS/eDMS administration, deviations, CAPAs, change controls, and investigations, with a mandate to drive process improvements and regulatory readiness.

The candidate will manage training, provide system support, and collaborate with QA, IT, and regulatory teams.