Clinical Quality Assurance Leader — GCP/GLP/GPV

Regulatory Jobs; Lexington (MA); Hybrid; USD 188,000 - 204,000; Full time

Job summary

Kiniksa Pharmaceuticals seeks an Associate Director of GCP Quality to lead QA activities across clinical development, including audits, investigations, and inspections. This office-based role supports GCP/GLP/GPV oversight and ensures studies comply with SOPs and global regulations, including FDA and ICH guidelines.

The position emphasizes collaboration with cross-functional teams, risk-based strategies, and strong communication to promote sustainable compliance in a fast-paced environment at

Qualifications

• B.S degree in life sciences with 10+ years of progressive global quality/regulatory compliance background in pharma/biotech or medical device industries, with a hands-on role in clinical quality operations and quality system preferred
• Advanced degree (MS, PhD, MBA) preferred; in lieu of advanced degree, additional years of equivalent experience will be considered
• Auditor certifications a plus

Responsibilities

• Provide professional expertise on GCP, GLP and GPV regulations to clinical development teams and identify compliance risks
• Lead clinical quality strategy and ensure inspection readiness
• Liaise with contract auditors and investigator sites to promote high quality and consistency
• Lead investigations into significant quality issues and develop appropriate CAPAs
• Manage audits of sites, documents, and processes in line with GCP/GLP/GPV and SOPs
• Contribute to health authority inspections and pre-inspection preparation

Skills

GCP Quality Assurance

Audit strategy

Inspection readiness

Regulatory compliance

Education

Bachelor of Science in life sciences

Advanced degree

Tools

Veeva Quality Docs

Veeva QMS

Regulatory submissions system

Job description

Kiniksa Pharmaceuticals seeks an Associate Director of GCP Quality to lead QA activities across clinical development, including audits, investigations, and inspections. This office-based role supports GCP/GLP/GPV oversight and ensures studies comply with SOPs and global regulations, including FDA and ICH guidelines.

The position emphasizes collaboration with cross-functional teams, risk-based strategies, and strong communication to promote sustainable compliance in a fast-paced environment at