Associate Director, Clinical Quality Management
The Associate Director, Clinical Quality Management, is a leadership position within the clinical quality team at Kyowa Kirin North America, a global specialty pharmaceutical company focused on innovative therapies in oncology, nephrology, and rare diseases. The role is integral to the clinical operations organization and provides strategic oversight on the quality management of clinical trials and research programs, ensuring compliance with all relevant regulations and internal standards across North American operations.
Key responsibilities include establishing, implementing, and maintaining quality management systems for clinical development activities, including the auditing of clinical trials, investigator sites, vendors, and internal processes. The Associate Director plays a major role in risk management and mitigation, facilitates the resolution of quality issues, and leads cross-functional initiatives to drive continuous improvement in clinical trial conduct and documentation.
The ideal candidate holds an advanced degree in a scientific or healthcare discipline with extensive experience in clinical quality management within the biopharmaceutical industry. Strong working knowledge of GCP, FDA, and ICH regulations is required, along with demonstrated experience managing audits, inspections, and CAPA processes. Excellent communication, project leadership, and stakeholder management skills are essential for success in this role.
Compensation for this position includes a competitive base salary, annual bonus opportunities, and a comprehensive benefits package featuring health, dental, and vision coverage, retirement plans, paid time off, and professional development support. Additional perks may include hybrid work arrangements and wellness programs.
Kyowa Kirin North America fosters a collaborative and diverse work environment that encourages innovation, learning, and career growth. The company is committed to improving patient outcomes through science, making it an inspiring workplace for those motivated by meaningful impact in healthcare.