Senior Director, Quality Assurance Corporate Compliance

Quality Systems & Compliance:• Ensure systems and practices meet corporate and government standards and expectations• Provide expertise and guidance in interpreting government regulations and guidelines• Work with department personnel to ensure compliance with the quality system• Harmonize business practices to allow for maximum efficiency• Work with third party suppliers to ensure contractual arrangements are satisfied• Continue to build world-class quality systems• Develop, coach and train personnel to ensure that adequate technical understanding is consistently built in to day-to-day operations• Build the expertise to understand and manage modern quality systems• Present briefings to Operations Committees and Board Members• Ensure validation support for manufacturing and testing activities• Manage and oversee regulatory inspections (USFDA, EMEA, etc.)• Support projects related to plant expansions, new plants, etc.• Ensure that all Quality Assurance activities are conducted in compliance with applicable regulations and build in quality as a part of the day-to-day operations• Build world-class quality systems and improve the infrastructure of the Quality Assurance operations in support of future growth• Is a key player in a future automation plans and defines the strategic direction for these activitiesAdditional Job Functions: • Establish departmental goals and objectives, ensuring they support company goals and objectives• Responsible for establishing department budget and managing activities within budget• Translate strategic vision into clear goals for the organization.• Hands-on manager• Outstanding people managerPosition Summary: Responsible for Corporate Quality Assurance activities for MedImmune’s commercial manufacturing facilities in support of antibody, vaccine and small molecule manufacturing activities. Directs Managers/Supervisors at the sites and ensures that all Quality Assurance activities are performed according to MedImmune Quality Standards and all applicable regulatory requirements.Typical Education:BS/MS: Biochemistry, Virology, Biology, or ChemistryComputer Skills:Microsoft Outlook, Internet Explorer, MS Project, MS Excel, MS WordTypical Experience:15 years in Quality, 10 years in a managerial role experienceCLICK HERE TO APPLY MedImmune, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law. Job Title: Senior Director, Quality Assurance Corporate Compliance Location:  US-MD-Gaithersburg Status:  Full Time, Employee Job Category:  Sales/Retail/Business Development