Director of Clinical Quality Assurance

Director of Clinical Quality Assurance About the Company Innovative biopharmaceutical company Industry Pharmaceuticals 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 The Company seeks a visionary Director of Clinical Quality Assurance (CQA) to lead and innovate all aspects of quality assurance within the CQA team. This crucial role is essential for ensuring compliance with Good Clinical Practices (GCP) and all regulatory requirements. The successful candidate will be instrumental in setting quality objectives, developing strategic action plans, and establishing robust audit protocols. In this strategic position, you will inspire and guide the CQA group, foster a quality-driven culture across clinical operations, and spearhead continuous improvements to our quality systems and processes. Your collaborative efforts will connect you with cross-functional leadership, and you will serve as the primary liaison with regulatory agencies on CQA matters. Additionally, overseeing the CQA budget and resource allocation will be part of your responsibilities. Ideal candidates should hold a Bachelor's degree in a scientific discipline, with an advanced degree preferred, and possess at least 15 years of GCP CQA experience in the pharmaceutical sector. A minimum of 5 years in a senior leadership capacity is required, along with extensive knowledge of quality management systems and compliance frameworks. You should have a profound understanding of both domestic and international regulatory guidelines, experience managing external regulatory inspections, and a proven history of implementing continuous improvement initiatives. Excellent organizational, interpersonal, and communication skills are vital, as well as 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, and who excels in making strategic hiring decisions. Hiring Manager Title VP Global Quality Travel Percent 25% Functions CEO/President Non-Profit Management