What are the responsibilities and job description for the GMP Quality Assurance Senior Manager: Cell Therapy position at Legend Biotech US?
Requirements
- A minimum of a Bachelor's Degree in Science or equivalent technical discipline is required.
- A minimum of 8 years relevant work experience is required. Experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, MSAT or cell therapy is preferred.
- Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals is essential. Experience in supporting cell-based products is a plus.
- Strong knowledge of cell therapy process and experience in cGMP regulatory body audits are highly valued.
