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