Manager, Quality Assurance
Northern New Jersey - Remote possibility
Salary: 110k-120k
Haven't found the right opportunity? A cell and gene therapy focused bio-pharmaceutical manufacturer is seeking a Manager of Quality Assurance to join its rapidly expanding team! This company is a pioneer in cell and gene therapy and now is the perfect time to get in with this group as you will be an integral member of the team responsible for the growth and leadership of the QA group. With plans to develop combination products to use in conjunction with their proprietary small molecules the next Manager of Quality Assurance will need experience with aseptic manufacturing.
The Sr. Manager, Quality Assurance will have the following responsibilities:
- Coordinate daily activities for the QA team
- Provide expertise on tech transfer activities
- Review and approve SOPs, WIs, and Forms
- Assist and support during internal and external audits
- Manage Batch issuance and record tracking systems
The ideal candidate will have:
- Knowledge of investigations, CAPA, and change control/complaint processes
- 5+ years relevant experience; working knowledge of aseptic manufacturing
- 1+ year in supervisory or managerial position
- Experience in clinical and commercial manufacturing
