Global Quality Compliance Leader

Kiniksa Pharmaceuticals; Lexington (MA); On-site; USD 250,000 - 273,000; Full time

Job summary

Kiniksa Pharmaceuticals is seeking a Senior Director for Quality Compliance based in Lexington, MA. This role provides strategic leadership and oversight of global quality compliance programs, ensuring alignment with regulatory requirements.

You will develop and implement risk-based quality strategies, manage core quality systems, and oversee inspection readiness. The ideal candidate will have over 12 years of experience in QA within biotech, and an advanced degree in a scientific discipline.

This on-site position emphasizes regulatory compliance and collaboration across teams to improve patient outcomes.

Qualifications

• 12+ years of experience in Quality Assurance/Compliance within the pharmaceutical or biotechnology industry.
• Proven expertise in supplier quality management, product complaints, and inspection readiness.
• Extensive experience with regulatory inspections and health authority interactions.

Responsibilities

• Develop and implement a comprehensive, risk‑based quality compliance strategy aligned with global regulatory expectations.
• Oversee key quality systems including deviations, CAPAs, change control, and quality metrics.
• Serve as a senior quality advisor to executive leadership on compliance risks, trends, and mitigation strategies.

Skills

Leadership in Quality Assurance

Regulatory Compliance

Supplier Quality Management

Inspection Readiness

GMP/GCP/GLP Knowledge

Education

Advanced degree in a scientific discipline (MS, PhD)

Tools

Electronic Quality Management Systems (e.g., Veeva, TrackWise)

Job description

Kiniksa Pharmaceuticals is seeking a Senior Director for Quality Compliance based in Lexington, MA. This role provides strategic leadership and oversight of global quality compliance programs, ensuring alignment with regulatory requirements.

You will develop and implement risk-based quality strategies, manage core quality systems, and oversee inspection readiness. The ideal candidate will have over 12 years of experience in QA within biotech, and an advanced degree in a scientific discipline.

This on-site position emphasizes regulatory compliance and collaboration across teams to improve patient outcomes.