Assoc. Director, Clinical Quality Assurance

Kiniksa Pharmaceuticals seeks an Associate Director of Clinical Quality Assurance to lead GCP compliance and quality oversight across clinical development programs. The role involves managing audits, investigations, and regulatory inspections while ensuring adherence to company procedures and global regulations.

Responsibilities

• Provide GCP/GLP/GPV regulatory guidance to clinical teams and identify compliance risks
• Develop and implement risk-based audit and compliance strategies for clinical programs
• Conduct routine and non-routine quality assurance audits of investigator sites, vendors, and systems
• Lead investigations into quality issues and scientific misconduct; oversee corrective actions
• Liaise with internal teams and external parties to promote quality consistency across programs

Requirements

• Deep understanding and significant experience in GCP and compliance regulations
• Leadership and communication skills to conduct responsibilities independently
• Experience managing clinical audits, quality issues, and investigations
• Knowledge of GLP and/or pharmacovigilance oversight requirements
• Familiarity with FDA, EU, ICH, and national regulatory guidelines