QC CAR-T INVESTIGATIONS LEAD

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Our strength in healthcare innovation empowers us to build a  world where complex diseases are prevented, treated, and cured,  where treatments are smarter and less invasive, and  solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
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CAR-T is an innovative blood cancer treatment that uses the strength of the patient's own immune system.
The patient's T-cells are genetically modified to eliminate the cancer cells.
This advanced technology offers hopeful prospects to patients for whom other therapies provide no or insufficient results.
We are therefore working passionately on expanding our capacity for CAR-T treatments in Europe, both at our existing site in Beerse and in Ghent, where we have developed a new production site.
We are looking for strong talents who are eager to participate in this innovative and hopeful venture.
The Innovative Medicine Supply Chain Group, a member of the Johnson & Johnson family of companies, is therefore recruiting a QC CAR-T investigation coordinator lead for the CAR-T hub in Europe.
The position will be based in Beerse Belgium.
The QC CAR-T investigation coordinator lead is responsible for oversight of the investigation coordinator team within QC CAR-T beerse, ensuring GMP compliance, accuracy and timeliness of deviations and managing a team.
The QC CAR-T Investigation Coordinator lead carries out duties in compliance with all local, state and federal regulations and guidelines (including EMA, FDA, …) as well as all company and site policies and procedures.
This position is responsible for carrying out supervisory responsibilities in accordance with the organization’s policies and applicable laws.
Responsibilities include interviewing, hiring, performance review, rewarding and disciplining employees, addressing complaints, resolving conflict and supporting internal and external audits.
Your tasks and responsibilities within the QC team are the following.
Oversee timely completion of laboratory investigation of OOS/ invalid assays, CAPAs and change controls Mentor, train and supervise QC CAR-T investigation coordinators Support daily operations within QC, work closely together with supervisors, analysts, production, warehouse and QA.
Leading complex investigations and writing a final investigation report based on a thorough root cause analysis.
You define, implement corrective actions and monitor their effectiveness, ensuring timely execution and closure.
If it concerns a cross-departmental QC investigation, you will manage a multi-disciplinary team.
You are the QC representative in cross-departmental investigations.
Supporting, initiating and implementing improvement projects for the team in the areas of safety, quality, efficiency and customer satisfaction.
Develop training/awareness sessions within QC.
Providing support during health authority inspections, including by preparing substantive questions.
Monitoring and streamlining the quality level within the various labs.
Managing a team of Investigation coordinators within the QC CAR-T department based on assigned work, direction, coaching and developing capabilities.
Set priorities and manage work assignments.
Communicate department objectives and metrics.
Maintaining detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training requirements.
Maintain individual training completion in a compliant state.
Evaluate performance and provides opportunities for growth.
Communicate department objectives and metrics.
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Establish and maintain effective working relationships with business and quality partners to ensure alignment of objectives and deliverables.
Proactively and continuously challenge the organizational performance and develop and implement improvements in organizational performance.
Qualifications A minimum of a Master’s degree in a biochemistry and biotechnology related degree.
A minimum of 2 years of people management experience is required.
Knowledge of cGMP regulations and FDA/EU guidance is required.
High organizational skills and independent and flexible way of working are required.
Excellent written and oral communication skills are required.
Professional experience in a GMP-regulated environment, preferably in the area of quality control, is an advantage.
Very good knowledge of using Microsoft Office programs.
A good knowledge of laboratory processes and systems is preferred.
Prior experience in cell and gene therapy is preferred.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.