Participate in training initiatives, project team meetings, and maintain relationships with other departments. A comprehensive knowledge of current FDA regulations and guidelines also required. Strong leadership along with excellent verbal and written communication skills are essential. Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail required. Experience with Microsoft based applications and general knowledge of PC functions necessary.
Experience managing direct contact with regulatory agencies is preferred.
Direct the Quality Assurance programs to support product in late phase clinical trials and into commercialization Implement and manage a comprehensive quality system for GMP manufacturing and product release that will become the benchmark for the company. Oversee documentation control and compliance functions within quality organization. Review and analyze method and process validation procedures. Oversee internal and external GMP audits. Interact with manufacturing and process development to implement efficient and effective systems for controlling the GMP manufacturing process.