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Clinical director • aurora co
- [promoted]
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Executive Director, 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
- and drug delivery
- retinal disease
- npdr
- dme
- tyrosine kinase inhibitors
- and ophthalmology
Business Classifications
About the Role
The Company is seeking an Executive Director for Clinical Quality Assurance (CQA) to lead and oversee all aspects of quality assurance within the CQA team. This strategic role is pivotal in ensuring that all Good Clinical Practices (GCP) related activities meet the necessary quality standards and that the company is in compliance with all GCP and governmental regulations. The successful candidate will be responsible for setting quality objectives, formulating strategic action plans, and establishing audit protocols. They will also provide leadership and guidance to the CQA group, shape the quality culture across the clinical organization, and drive continuous improvement in quality systems and processes. The role involves collaboration with cross-functional leadership, serving as the primary liaison with regulatory agencies on CQA matters, and managing the CQA budget and resource allocation.
Applicants for the Executive Director position must have a Bachelors degree in a scientific discipline or related field, with an advanced degree preferred, and at least 15 years of GCP CQA experience in the pharmaceutical industry. A minimum of 5 years in a senior leadership role is required, along with a strong background in QMS and compliance systems. The ideal candidate will have a deep knowledge of domestic and international regulatory guidelines, experience with external regulatory inspections, and a proven track record of driving continuous improvement initiatives. Excellent organizational, interpersonal, and communication skills are essential, as is the ability to mentor and develop a high-performing CQA team. The role demands a leader who can provide executive-level guidance on quality risk management and CAPA, and who is adept at managing strategic hiring decisions.
Hiring Manager Title
VP Global Quality
Travel Percent
25%
Functions