Director of Quality Assurance

• Lead the Quality team supporting Analytical activities including method qualification/validation, method transfer, establishing specifications and justification for specifications and stability protocols (clinical and commercial), data and reports.
• Ensures quality staff performs and approves root cause analysis and product impact assessments for investigations resulting from deviations.
• Ensures quality staff assesses and approves change controls
• Ensure regulatory submissions align with filing strategy. Review and approve submission amendments.
• Ensure review of batch data, including batch records, deviations, and other quality systems as applicable to determine acceptability of product disposition

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.