QA Investigations Specialist

Il y a 2 mois

Gent, Belgique Legend Biotech EU Temps plein

**Company Information**

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.

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) in 2017. 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 QA Investigations Specialist, with focus on Investigations and Change Controls, is part of the QA Project Support Team.

The QA Investigations Specialist is responsible for conducting thorough investigations into non-conformances occurred during operational QA activities in both clinical and commercial batches manufactured at Legend Biotech Belgium. This role also involves managing the change control process to ensure all Quality Operation change controls are assessed, documented, and implemented in compliance with regulatory requirements and company policies.

**Major Responsibilities**
- Investigations:

- Conduct detailed investigations into non-conformances
- Gather and analyze data to identify root causes.
- Develop and implement corrective and preventive actions (CAPAs).
- Document investigation findings and ensure timely closure of reports.
- You are in close contact with multiple departments (Operations, Supply Chain, QC, QA,).
- Ensure accurate and timely maintenance and review of investigations, CAPAs
- Change Control:

- Coordinate the change control process for all changes impacting product quality, safety, and efficacy.
- Review and assess change control requests for completeness and accuracy.
- Facilitate change control meetings and ensure all stakeholders are informed.
- Track and monitor the implementation of approved changes.
- Ensure accurate and timely maintenance and review of change controls
- Continuous Improvement:

- Identify opportunities for process improvements and contribute to the development of best practices.
- Provide training and support to staff on investigation and change control procedures.
- You will be responsible for drafting necessary documents, including Standard Operating Procedures and Work Instructions for the users.
- Monitor and report on progress of the project goals and operational project KPIs
- Support regulatory inspections and audits by ensuring inspection readiness within facility.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Strive to reduce non-conformances in supported areas by proactively driving compliance.

**Qualifications**

**Education**

A minimum of a Bachelor's Degree or relevant years of experience within the pharmaceutical industry.

**Experience**
- A minimum of 2 years relevant work experience is required.
- Prior experience in pharmaceutical manufacturing or quality, is required.

**Key Capabilities, Knowledge, and Skills**
- Knowledge of cGMP regulations and EMEA guidance related to manufacturing of cell-based products.
- Excellent analytical, problem solving, and organizational skills
- Effective communication and interpersonal skills
- Proficiency in using quality management systems and software
- Experience with root cause analysis tools and techniques.
- Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
- Must be able to create a highly collaborative and inclusive environment necessary for the team to be effective.
- Flexible mindset capable to deal with ambiguity and to respond quickly, energetically, and enthusiastically to changes.
- Self-motivated, enthusiastic personality, team player, with a desire to learn new skills.
- Ability to work in (transversal) teams - Team spirit.
- Can do attitude, right first time.
- Great attention to detail and ability to 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 must.
- Must exhibit strong leadership skills and effectively develop others.
- Ability to collaborate well with stakeholders, 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.

**Language Requirements**

Dutch and/or English

Legend Biotech mainta

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