QA Supervisor Qpip
il y a 3 jours
**Company Information**
Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.
**Role Overview**
The QA Supervisor QPIP, CAR T, is an exempt level position with responsibilities for providing quality oversight over the production of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This role includes supervision of QA shop floor personnel as well as working with manufacturing to troubleshoot issues. This role will work in shift regimes supporting the 7/7 days cell processing.
**Major Responsibilities**:
- Lead, train and support QPIPs (Quality persons in plant) in support of cell therapy manufacturing
- Ensure Quality Oversight in plant covering various process related activities and supports real time review of documentation in support of process unit operations and release activities where needed.
- Ensure periodic Quality checks/audits related to process, documentation and handling are performed
- Strive to reduce non-conformances and deviations together with the team in supported areas by proactively driving compliance.
- Ability to read, interpret and revise documents such as SOPs, work instructions.
- Develop positive relationship with the QA team, Quality Control, Information Technology, Maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members, and peers.
- Harmonize with Environmental, Health, and Safety personnel, Product Development, and Quality/Manufacturing personnel.
- Independently makes appropriate and compliant GMP decisions.
- Independently resolves problems through the use of quality systems.
- Develop improvement ideas and independently implement associated solutions.
- Support QPIP team development.
- Possess the ability to positively influence peers, key stakeholders and management.
- Generates shift schedules, to ensure efficient coverage for all operational needs.
- Maintain individual training completion in a compliant state.
- Supports the completion of corrective and preventive actions, as necessary.
- Supports internal/external audits.
- Supports Quality risk assessment teams.
- Review/approve documents as a Quality on the Floor Subject Matter Expert (SME).
- Remain current in skills and industry trends.
- Detailed knowledge of Quality and Compliance standards.
**Qualification**
**Education**:
A minimum of a Bachelor's Degree in Science, Information Science or equivalent technical discipline is required.
**Experience**:
**Capabilities, Knowledge, and skills**:
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
- Strong interpersonal and written/oral communication skills.
- Ability to quickly process complex information and often make critical decisions with limited information.
- Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
- Ability to independently be responsible for a portfolio of ongoing projects.
- Ability to pay attention to details and follow the procedures
- Good written and verbal communication skills are required.
- Ability to summarize and present results, and experience with team-based collaborations is a requirement.
- Experience directly supervising employees is preferred.
- Ability to work with and lead others in a team environment.
- Experience developing and setting long-term objectives.
- Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
- Ability to identify/remediate gaps in processes or systems
- Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
- Experience reviewing/auditing documentation including but not limited to: Batch Records, SOPs, Work Instructions, Validation protocols.
- Flexible to work on weekends.
**Language(s)**:
Dutch & Technical English
LI-AG1
LI-Onsite
Legend Biotech maintains a drug-free workplace.
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