Global Quality & Compliance Director

Regulatory Jobs; Lexington (MA); On-site; USD 250,000 - 273,000; Full time

Job summary

Kiniksa Pharmaceuticals, based in Lexington, MA, seeks a Senior Director of Quality Compliance to lead global quality programs onsite five days a week. The role focuses on supplier oversight, product complaints, and inspection readiness, partnering across regulatory, CMC, Clinical, and Manufacturing functions.

You will drive risk-based strategies, evolve QMS platforms (Veeva/TrackWise), and mentor high-performing teams to ensure compliant development through commercialization.

Qualifications

• 12+ years in QA/Compliance within the pharmaceutical/biotech industry.
• Leadership in GMP, GCP, and/or GLP across development and commercial stages.
• Extensive experience with regulatory inspections and health authority interactions.
• Proven expertise in supplier quality management and product complaints.

Responsibilities

• Provide strategic leadership of global quality compliance programs.
• Oversee supplier quality management for CMOs, CROs, and vendors.
• Lead inspection readiness and serve as inspection lead for authorities.
• Drive CAPAs, deviations, change control, and quality metrics.
• Collaborate with cross-functional teams to mitigate quality risks.
• Champion a culture of quality and continuous improvement.

Skills

Quality strategy

Executive collaboration

Cross-functional leadership

Risk-based decision making

Education

Advanced degree in scientific discipline (MS/PhD)

Tools

Veeva

TrackWise

Job description

Kiniksa Pharmaceuticals, based in Lexington, MA, seeks a Senior Director of Quality Compliance to lead global quality programs onsite five days a week. The role focuses on supplier oversight, product complaints, and inspection readiness, partnering across regulatory, CMC, Clinical, and Manufacturing functions.

You will drive risk-based strategies, evolve QMS platforms (Veeva/TrackWise), and mentor high-performing teams to ensure compliant development through commercialization.