- Posted 18 April 2023
- Job type Permanent
- Contact NameNatasha Cole
At BioTalent, we are working with a client exclusively to fill their QA Manager position. They are a transformative clinical-stage biotechnology company focused on developing next-generation viral immunotherapies to treat cancer.
You will be responsible for establishing quality initiatives to support a new facility start-up including system implementation, process transfer and manufacturing.
This role will offer you
- To work in a fast-paced environment and the ability to take a huge impact.
- To be a key individual with a huge impact in expanding the operations team.
- Exposure to high visibility from the senior leadership team.
- Opportunity to join one of the most rapidly expanding biotechnology companies.
- Work at the forefront of science.
You will be responsible for
- Ensuring GMP compliance by implementing continuous improvement strategies on the Pharmaceutical Quality System to ensure compliant manufacturing
- Building the QA operations team focused on supporting cGMP manufacturing activities (e.g. shop floor support, inspections, and making real time decisions related to operations.
- Deviation management including coordinating risk assessments and change controls
- Performing batch disposition
You will bring the following
- Extensive operational QA experience within a GMP compliant environment
- Experience with cell, protein, RNA, and/or viral products and regulatory standards is preferred
- Experience with both early and late phase clinical manufacturing preferred.
- BSc or MSc in a relevant Life Sciences subject