Ability to communicate with all levels of internal and external customers including but not limited to: patients and families, providers, clinical personnel, support and technical staff, external customers, and community agencies.
Directs the staffing and training needs to meet expected requirements as defined for a highly reliable organization. Develops and implements an audit/education plan that uses feedback from audits to perform direct communications/trainings to impact future audit findings and continue the HRO path.
Collaborate and establish procedures with technical operations and manufacturing staff to ensure that clinical supply and commercial manufacturing activities are conducted in compliance with applicable GMP requirements.
Responsible for total compliance with all applicable corporate policies and procedures, corporate and divisional specifications, local standard operating procedures, 510K requirements, and all other applicable regulatory requirements.
The Director of Quality Systems develops, establishes, implements and maintains effective quality systems through policies, processes, procedures and controls that ensure process and product quality and compliance with global regulatory agencies.