My client is a Rockville Maryland area Pharmaceutical company
The Senior Director, Quality Assurance (QA) will be responsible for the development and execution of the World- Wide Quality Organization and Management Systems. You will assure that QA and global policies and procedures are designed and implemented as required by the applicable regulations for Infectious Disease Therapeutics for the US, Europe and African countries.
- Advanced degree in pharmacy, chemistry or life sciences highly desirable.
- At least 15 years’ experience in quality assurance, with working knowledge and/or demonstrated expertise in GxP regulations and guidelines and experience in designing a QM system across the organization
- Familiar with regulatory issues and inspections with multiple regulatory agencies, including the preparation for, conduct of, and responses to inspections
Knowledge, Skills and Abilities
- Extensive knowledge in a broad range of pharmaceutical activities and quality systems
- Direct experience interpreting regulations effectively to manage regulatory risks