Quality Assurance Manager
AntriaBio is a clinical stage biopharmaceutical company specializing in the development of innovative drug therapies to improve the lives of patients with diabetes and metabolic diseases. AntriaBio's lead product candidate is AB101, an injectable once-weekly basal insulin for Type 1 and Type 2 diabetes that addresses a $11 billion market where the current standard of care is a once-daily basal insulin injection.
The QA Manager is responsible for ensuring compliance to written procedures; establishing and maintaining quality systems; and providing GMP guidance to Operations and Quality Control.
- Provide Quality oversight to ensure product is manufactured, tested, stored and distributed according to cGMPs and other applicable regulations
- Support Quality Systems (Change Management, Document Control, Deviations/CAPA, Batch Record Review)
- Support Facilities and Engineering with protocol and work order review/approval
- Develop, implement and maintain phase appropriate Quality Systems
- Perform internal and external Quality audits
- Disposition materials
- Draft and revise standard operating procedures
- Oversight of maintenance and calibration program
- Work cross functionally to achieve goals on tight timelines
- Coaching of staff
- Communicating clearly with staff and management team
Experience and Required Skills:
- BS or BA in Life Sciences or related field with a minimum of eight years in a biopharmaceutical GMP environment. Relevant work experience may be substituted in lieu of education.
- Experience in a biopharmaceutical GMP or GLP environment
- Knowledge of protein therapeutics a plus
- Ability to work cross functionally
- Microsoft Office