Associate Director, Clinical Quality Assurance - GCP/GLP Leadership

Regulatory Toolkit; Lexington (MA); On-site; USD 188,000 - 204,000; Full time

Job summary

Kiniksa Pharmaceuticals is seeking an Associate Director of GCP Quality to lead Clinical Quality Assurance for clinical development programs, managing audits, investigations, and inspections. The role requires deep GCP/GLP/GPV expertise, leadership, and strong communication across global teams.

The position is onsite in Lexington, MA, with five days per week in the office. Salary is competitive, with emphasis on regulatory compliance and quality system excellence.

Qualifications

• 10+ years global quality/regulatory compliance in pharma/biotech or medical devices.
• Experience with Phases I-IV and regulatory submissions.
• Auditor certifications a plus.

Responsibilities

• Lead GCP/GLP/GPV QA activities for clinical development programs.
• Manage audits, quality issues, investigations, and inspections.
• Develop risk-based audit/compliance strategies and CAPA programs.
• Collaborate with cross-functional teams to ensure compliance across programs.

Skills

GCP Quality Leadership

Audit Strategy

Inspection Readiness

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Education

B.S. in Life Sciences

Advanced Degree Preferred

Tools

Veeva Quality Docs

Veeva Training

Veeva QMS

Job description

Kiniksa Pharmaceuticals is seeking an Associate Director of GCP Quality to lead Clinical Quality Assurance for clinical development programs, managing audits, investigations, and inspections. The role requires deep GCP/GLP/GPV expertise, leadership, and strong communication across global teams.

The position is onsite in Lexington, MA, with five days per week in the office. Salary is competitive, with emphasis on regulatory compliance and quality system excellence.