This position will establish, improve and implement global quality strategies and systems encompassing the entire product life cycle in accordance with regulatory requirements. The systems are to include review of all GMP related documents, label review, EPA reporting, internal auditing, nonconformance/CAPA, and Management Reviews. The systems will need to be in compliance with domestic and international cGMP requirements for cosmetic, medical device, over the counter drug & EPA products.
- Create, maintain and implement global quality policies and the global quality manual. Teams with HR to manage global training programs and serves as the GQA training representative.
- Supervises the internal c GMP audit program. Coordinates management review, and mock recall programs. Assembles and publishes global metrics on compliance and quality system performance.
- Hire, mentor, and lead direct reports. Provide training to staff and personnel in cGMP quality management system requirements for Cosmetic, Medical Device, OTC Drug and EPA product manufacturing, as needed.