QA Manager

Posted 18 April 2023
Job type Permanent
Contact NameNatasha Cole

Job description

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