Clinical Quality Assurance Director

Clinical Quality Assurance Director 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 seeking a visionary Clinical Quality Assurance Director to lead our dynamic CQA team. This pivotal role is essential for ensuring compliance with Good Clinical Practices (GCP) and all regulatory frameworks. You will play a vital role in establishing quality objectives, developing strategic action plans, and creating robust audit protocols. As a strategic leader, you will inspire and guide the CQA group, promote a quality-driven culture across clinical operations, and drive continuous improvements in our quality systems and processes. Collaboration with cross-functional leadership will be key, and you will act as the primary liaison with regulatory agencies on all CQA matters. Additionally, you will oversee the CQA budget and resource allocation. The ideal candidate should possess a Bachelor's degree in a scientific discipline, with an advanced degree preferred, along with at least 15 years of GCP CQA experience in the pharmaceutical sector. A minimum of 5 years in a senior leadership position is required, as well as extensive knowledge of quality management systems and compliance frameworks. You should have a deep understanding of both domestic and international regulatory guidelines, experience in overseeing regulatory inspections, and a proven track record of implementing continuous improvement initiatives. Strong organizational, interpersonal, and communication skills are essential, along with the ability to cultivate and mentor a high-performing CQA team. This role demands a leader who can provide executive-level insight on quality risk management and CAPA, excelling in strategic hiring decisions. Hiring Manager Title VP Global Quality Travel Requirement 25% Functions CEO/President Non-Profit Management

Created: 2026-03-04