Legend Biotech US is hiring an Associate Manager, QA Shop Floor to provide quality oversight for the production of personalized cell therapies to support clinical and commercial requirements in a sterile GMP environment. This exempt-level position involves supervising QA shop floor personnel and collaborating with manufacturing to troubleshoot issues.
What You'll Do
- Read, interpret, and revise documents such as SOPs and work instructions.
- Develop positive relationships with cross-functional teams including Quality Control, Manufacturing, and Site Leadership.
- Independently make appropriate and compliant GMP decisions and resolve problems using quality systems.
- Lead quality-driven continuous improvement projects to reduce non-conformances.
- Support team growth and development, and generate shift schedules for operational coverage.
- Maintain quality practices per state and federal regulations.
- Support corrective actions, internal/external audits, and quality risk assessment teams.
- Review and approve documents as a Quality on the Floor Subject Matter Expert.
- Remain current in skills and industry trends.
- Perform job duties that routinely involve exposure to biological materials and hazardous chemicals.
- Meet specific visual acuity and color perception requirements.
What We're Looking For
- A Bachelor’s Degree in Science, Engineering, or an equivalent technical discipline.
- A minimum of 1 year of relevant work experience, preferably within a biological or pharmaceutical industry.
- Knowledge of Good Tissue Practices.
- Excellent written and oral communication skills.
- The ability to accommodate a shift schedule, including routine weekend and evening work, and unplanned overtime.
- A highly organized candidate capable of working in a team environment under some supervision.
- Comfort speaking and interacting with regulatory inspectors.
- Willingness for occasional travel to partner sites in NJ or PA, and up to 5% domestic or international travel.
- A results-oriented professional who takes initiative and is willing to take unpopular positions when necessary.
Nice to Have
- Experience in a Quality Control setting.
- Experience with processing samples in biosafety cabinets utilizing aseptic technique.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products.
- Knowledge of CAR-T QC test methods and related equipment.
Team & Environment
This role is part of the Quality team, providing direct oversight on the shop floor.
Work Mode
This position is onsite at our Raritan, NJ location.
Legend Biotech US is an equal opportunity employer.
