Senior Quality Systems & Compliance Leader

Mount Kemble Search Group; Portsmouth (NH); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Equity participation

Life and AD&D insurance

401(k) matching

Discretionary paid time off

Opportunity to scale QMS

Job summary

Mount Kemble Search Group seeks an experienced Quality Systems & Compliance Lead to join a clinical-stage organization developing pharmaceutical and combination-product technologies. This hands-on role owns the QMS during regulatory activity and product development.

The successful candidate will manage audits, inspections, and compliance with FDA, ISO 13485, and 21 CFR Part 4 requirements while guiding cross-functional teams to scalable, practical processes in a fast-paced environment.

Qualifications

• Bachelor-level degree in a technical field related to quality or life sciences.
• 7+ years in Quality Assurance, Quality Systems, or regulatory/compliance within medtech, pharma, or combination products.
• Experience owning Quality System processes in FDA-regulated environments.
• Hands-on audit management and participation in regulatory inspections.
• Strong knowledge of FDA Quality System requirements and eQMS usage.

Responsibilities

• Own and manage QMS processes, including procedures, updates, and continuous improvement.
• Lead audits, internal and external, and manage findings and CAPA.
• Prepare for and participate in regulatory inspections and inspections readiness.
• Drive compliance with 21 CFR Part 4, ISO 13485, and applicable drug/device requirements.
• Develop quality metrics, dashboards, and management reporting for leadership.
• Collaborate across Development, Manufacturing, Regulatory, and Supply Chain.

Skills

Quality Assurance

Quality Systems

Regulatory Affairs

FDA Compliance

Audits

CAPA

Documentation

Leadership

Cross-functional Collaboration

Education

Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Pharmaceutical Sciences

Tools

eQMS

Job description

Mount Kemble Search Group seeks an experienced Quality Systems & Compliance Lead to join a clinical-stage organization developing pharmaceutical and combination-product technologies. This hands-on role owns the QMS during regulatory activity and product development.

The successful candidate will manage audits, inspections, and compliance with FDA, ISO 13485, and 21 CFR Part 4 requirements while guiding cross-functional teams to scalable, practical processes in a fast-paced environment.