Quality Assurance Director is responsible for the implementation of policies and procedures to ensure adherence to production quality standards. Monitors and audits process, material, and product testing against established standards and conducts a continuous analysis of quality defects and deviations. Being a Quality Assurance Director identifies deficiencies or gaps in testing activities and develops solutions to ensure adequate and robust quality processes. Optimizes processes to comply with existing and new regulatory requirements. Additionally, Quality Assurance Director typically requires a bachelor's degree. Typically reports to a director. The Quality Assurance Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Quality Assurance Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
As the Associate Director of Quality Control Microbiology, you will have oversight of all microbiological testing for cell therapy clinical and commercial production. You will be required to work on the plant floor side by side with production personnel and QAOTF to identify and correct microbial deficiencies. You will also participate in the implementation of Corporate Strategies and work with lead investigator as SME for potential microbial testing failure, including sterility assurance
Essential Skills/Experience:
- Requires a Bachelor’s Degree in Microbiology, Biological Sciences or related discipline.
- 8 years of experience in biopharma, medical device, or pharmaceutical manufacturing.
- 6 years of experience with Advanced Degree (MS or PhD).
- 2 years of managerial/supervisory experience.
- Ability to work in a matrix environment.
- Excellent communication skills (with staff, peers and upper management) and ability to develop rapport with other functional leaders to influence decision-making.
- Ability to make effective decisions and do so in the absence of complete information and when under pressure.
Desirable Skills/Experience:
- Advanced Degree desired.
- Project Management experience.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.