Senior Manager QA Operations
il y a 4 semaines
**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 **Senior** **Manager QA Operations** is a management level position responsible for QA Release and Quality oversight over the production operations for personalized cell therapy for both clinical and commercial purpose in a sterile GMP environment. This includes hiring, development and performance management of staff and teams, reviewing/approving operational procedures, supporting and ownership of release activities.
The position will be responsible for QA Incoming Materials, QA Batch Documentation and QA Batch Release. The position will also be responsible for shop floor QA oversight on manufacturing processing and logistic center operations. This role will take up the lead for the QA Release Operations for Obelisc or TechLane facility.
**Major Responsibilities**:
- Establish and maintain QA teams supporting the daily Quality Assurance Release activities.
- Responsible for technical release activities for incoming production materials, intermediates and final product.
- Responsible for Batch Documentation management for manufacturing.
- Responsible for Batch Record Review, BRR process and improvement.
- Responsible for providing QA oversight on the manufacturing shop floor.
- Review and approve manufacturing and QA procedures.
- Ensure timely release through collaboration with site functions and QC.
- Support all activities for site Quality Operations in accordance established standards, procedures and cGMPs.
- Support and perform review of manufacturing investigations, CAPAs and complaints, as necessary.
- Support regulatory filings by ensuring site data is verified and accurate.
- Serves as the Quality person in plant in support of cell therapy manufacturing.
**Key Relationships**:
- Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Quality department, Maintenance, Supply Chain and Planning
**Qualifications**
**Education**:
- A minimum of a Master Degree in Pharmaceutical/Biological/Biochemical Science/Bio engineering related or equivalent technical discipline is required.
**Experience**:
**Key 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.
- Leadership, project and people management skills
- Good written and verbal communication skills are required.
- Ability to summarize and present results, and experience with team-based collaborations is a must.
- Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk.
- Must exhibit strong leadership skills and effectively develop others.
- Ability to collaborate well with stakeholders, partners, customers and peers.
- Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
- Must be able to discern the criticality of issues and to communicate to management regarding complex issues.
- Ability to manage conflict and issues that arise with internal or external customers.
- Great attention to detail and ability to follow the procedures.
***Language Requirements**
Dutch and technical English
LI-AG1
Legend Biotech maintains a drug-free workplace.
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