Senior Director, Quality Compliance

Responsibilities

• Develop and implement a comprehensive, risk-based quality compliance strategy aligned with global regulatory expectations (FDA, EMA, MHRA, ICH)
• Provide executive oversight of core quality systems to ensure consistent compliance and operational effectiveness
• Establish and maintain a robust global supplier quality management program for CMOs, CROs, and critical vendors
• Provide strategic oversight of the global product quality complaint program, including investigations and regulatory reporting
• Lead global inspection readiness strategy and serve as the primary point of contact for regulatory agency inspections
• Oversee key quality systems including deviations, CAPAs, change control, and quality metrics
• Drive harmonization and optimization of QMS processes and digital platforms
• Lead, develop, and mentor high-performing quality teams across multiple regions

Requirements

• Advanced degree in a scientific discipline (MS, PhD preferred)
• 12+ years of experience in Quality Assurance/Compliance within the pharmaceutical or biotechnology industry
• Demonstrated leadership experience in GMP, GCP, and/or GLP environments
• Extensive experience with regulatory inspections and health authority interactions
• Proven expertise in supplier quality management, product complaints, and inspection readiness
• Strong knowledge of global regulatory requirements (FDA, EMA, ICH)
• Experience with electronic Quality Management Systems such as Veeva or TrackWise
• Ability to travel up to 30%

About the Company

Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications.