Director of Clinical Quality Assurance

Director of Clinical Quality Assurance About the Company Join an innovative biopharmaceutical company dedicated to advancing healthcare solutions. Industry Pharmaceuticals Company Type Public Company Founded 2006 Employees 51-200 Specialties Ocular drug delivery Surgical sealants Sustained delivery Ophthalmic therapies Ophthalmology Optometry Retina Cataract Glaucoma Wet AMD Anti-VEGF Drug delivery Retinal disease NPDR DME Tyrosine kinase inhibitors Business Classifications B2B Enterprise About the Role We are looking for a passionate and strategic Director of Clinical Quality Assurance to lead our esteemed CQA team. This key position is crucial for ensuring adherence to Good Clinical Practices (GCP) and various regulatory standards. You will be instrumental in setting quality objectives, developing comprehensive action plans, and establishing robust audit protocols. As a strategic leader, you will motivate and guide the CQA team, fostering a culture of quality across clinical operations while driving continual enhancement in our quality systems. Collaboration with cross-functional leadership will be essential, as you serve as the leading liaison with regulatory agencies regarding all CQA issues. Moreover, you will manage the CQA budget and resource distribution. The ideal candidate should have a Bachelor's degree in a scientific field, with a preference for an advanced degree, and at least 15 years of experience in GCP CQA within the pharmaceutical industry. A minimum of 5 years in a senior leadership role is required, along with extensive knowledge of quality management systems and compliance frameworks. A thorough understanding of domestic and international regulatory guidelines, experience with regulatory inspections, and a successful record of implementing continuous improvement initiatives are essential. We seek someone with strong organizational, interpersonal, and communication capabilities, along with the ability to mentor and develop a high-performing CQA team. This position requires a leader who can provide executive-level insights on quality risk management and CAPA while excelling in strategic recruitment decisions. Hiring Manager Title VP Global Quality Travel Requirement 25% Functions CEO/President Non-Profit Management

Created: 2026-03-10