Senior QMS Leader (eQMS) - Onsite in Lexington

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

Job summary

Kiniksa Pharmaceuticals is seeking an Associate Director, Quality Management Systems, to lead the site’s GxP quality platforms, including eQMS and eDMS. The role ensures compliance with 21 CFR Part 11, drives process improvements, and partners with IT and QA peers to support policy alignment.

Based in Lexington, MA, the position requires on-site presence five days per week and a track record in quality systems leadership, metrics, and inspection support within a regulated bio/pharma setting.

Qualifications

• Bachelor's degree in a scientific or technical field with 8+ years QA/QMS experience.

Responsibilities

• Oversee eQMS/eDMS administration, including access, training, and validation.
• Administer deviation, CAPA, investigation, complaint, and change-control processes.
• Lead quality metrics development, trending, and reporting to senior leadership.
• Drive training and awareness of QMS capabilities across the organization.
• Manage the records lifecycle, retention, archiving, and retrieval of GxP records.
• Support inspection readiness activities and interact with regulatory inspectors.

Skills

Quality systems management

Regulatory knowledge

Cross-functional collaboration

Project management

Communication skills

Education

Bachelor's degree in scientific or technical field

Tools

Veeva Quality (QMS/QDocs)

Microsoft Excel

Job description

Kiniksa Pharmaceuticals is seeking an Associate Director, Quality Management Systems, to lead the site’s GxP quality platforms, including eQMS and eDMS. The role ensures compliance with 21 CFR Part 11, drives process improvements, and partners with IT and QA peers to support policy alignment.

Based in Lexington, MA, the position requires on-site presence five days per week and a track record in quality systems leadership, metrics, and inspection support within a regulated bio/pharma setting.