Be QA Excellence Manager
il y a 3 semaines
**Company Information**
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
**Role Overview**: The Manager, QA Excellence is an exempt level position with responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes hiring, development and performance management of staff, reviewing/approving operational procedures, supporting and approving manufacturing investigations and ownership of various department projects. She/he will be responsible for multiple work centers within the facility including tracking of quality metrics while ensuring high quality and complaint product supply.
**Major Responsibilities**:
- Support, maintain and design compliance and quality excellence for all on site operations.
- Collaborate with site personnel to provide guidance and determine resolution for manufacturing quality
- Support all activities for site Quality Operations in accordance with Legend and Janssen (where applicable) standards, procedures and cGMPs.
- Manage the daily activities for the quality compliance group.
- Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints
- Review and approve manufacturing procedures.
- Support regulatory inspections and audits by ensuring inspection readiness within facility.
- Perform internal housekeeping audits.
- Perform analysis on quality indicating data and identifying trends.
- Provide oversight for trending of quality compliance metrics.
- 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, Maintenance, Supply Chain and Planning.
**Qualifications**
**Education**:A minimum of a Bachelor's Degree in Pharmaceutical/Biological/Biochemical Science/Bio engineering related or equivalent technical discipline is required.
**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.
- 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.
**Legend Core Behaviors**
Ownership and Commitment
- Takes responsibility for one's results and deliverables; sets and achieves goals to support organizational priorities.
- Takes initiative; willing to take unpopular positions/actions when necessary; courageous and assertive.
- Works effectively in the face of ambiguity, shifting priorities, and rapid change; maintains a positive outlook in difficult situations; a change agent.
Agility and Prioritization
- Identifies and focuses on activities of highest value and impact; makes informed decisions quickly.
- Results oriented; defines goals, metrics and actionable plans and manages work to deliver desired outcomes; has a sense of urgency.
- Considers resources, alternatives, constraints and desired outcomes to make effective decisions.
- Employs good project management principles to appropriately align time, resources, and budgets.
Teamwork and Communication
- Appreciates diverse perspectives and is actively inclusive of others' input and ideas; treats others with respect.
- Articulates ideas clearly and succinctly in a variety of settings and styles; can get messages across that have the desired effect.
- Leverages personal credibility and interpersonal skills to help others make better decisions and positively impact outcomes; able to develop/maintain effective working relationships internally and externally.
- Employs a global mindset in decision-making and errs on the side of over-communicating to create organizational transparency, trust and alignment.
Continuous Improvement
- Actively pursues and shares kno
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