Senior Director, Quality Control – Frederick, MD
MedImmune is the global biologics research and development arm of AstraZeneca. We work as partners in bringing life changing medicines to patients, sharing and benefiting from each other's strengths.
Senior Director, Quality Control will be responsible for all aspects of Quality Control at the Frederick Manufacturing Center, including the testing of raw materials, in-process, drug substance, drug product, stability and microbiology samples in support of late stage clinical and commercial programs.
Main Duties and Responsibilities
As the Senior Director, Quality Control you will have the responsibility for the successful operation of activities of major significance to the organization. This role rarely becomes involved in daily operational activities instead is more concerned to see that overall budgets, schedules & performance standards are realistically set and attained. In this role you will apply extensive expertise as a generalist or specialist so will possess working knowledge of related disciplines. In addition you will apply on a broad base, principles theories & concepts. To maintain a high level of expertise in this role you will review current scientific literature, submissions to scientific journals & attend/participate at conferences.
- Individual will oversee all aspects of the late stage clinical and commercial drug product stability program, QC Analytical, QC Technical Services, QC Information Systems, QC Compliance Management, QC Planning, Environmental Monitoring or QC Sample Management.
- Support for method validation activities.
- Responsible for test result reporting and trending.
- Champion continuous improvement and Lean Six Sigma initiatives in QC.
- Individual will play a key role defining the values, culture, and goals for the site.
- Provide leadership, direction, and mentoring to ensure that the QC organization is successful in meeting the quality and manufacturing objectives in support of corporate goals.
- Provide strategic support to Global Technical Operations as a Subject Matter Expert.
- Lead external and internal customer relationships that ensures aligned deliverables.
- Facilitate as partner to FMC leadership team to develop and secure site deliverables.
- Facilitate the growth and development of QC staff.
- Serves as primary consultant and external spokesperson for Operations for matters relating to policy, capabilities, and long term goals.
- Demonstrate excellent communication skills through internal and external channels.
- Develops and manages succession and talent that align to long range operating plans.
- Bachelor’s degree
- Possess a comprehensive background in Analytical Chemistry and Microbiology with formal qualifications in one of these or related disciplines
- 15+ years experience in Commercial/Clinical Quality Organizations
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.