Analyst Quality Assurance

Johnson & Johnson Innovative Medicine; Oost-Vlaanderen; Sur place; EUR 60 000 - 96 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being programs

Résumé du poste

Johnson & Johnson Innovative Medicine in Ghent, Belgium, is recruiting a QA Associate for the CAR-T hub in Europe. You will report to the QA CAR-T organization and collaborate with cross-functional teams to ensure GMP/ATMP compliance and timely product release.

Key responsibilities include batch documentation review and release, investigate deviations and complaints, manage CAPAs, support inspections and audits, and contribute to QA oversight to safeguard patient safety.

Qualifications

• Degree in Pharmacy or Bio-engineering with QP certification.
• Minimum 3 years cross-functional experience in pharma.
• Strong GMP/ATMP knowledge and regulatory awareness.
• Excellent written and verbal communication.

Responsabilités

• Batch documentation review and release to verify regulatory compliance.
• Provide technical, quality, and compliance expertise for investigations.
• Manage deviations and complaints with thorough investigations.
• Ensure CAPA actions are identified and implemented.
• Assist in inspections and audits to ensure GMP compliance.
• Contribute to quality oversight and cross-functional collaboration.
• Support Vein-to-Vein, regulatory affairs, and other teams as needed.

Connaissances

QA Knowledge

GMP

ATMP

Analytical skills

Formation

Pharmacy

Bio-engineering

Qualified Person certification

Outils

QMS software

Description du poste

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Gent, East Flanders, Belgium

Job Description:

About Innovative Medicine

Ourexpertisein Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Johnson & J&J is recruiting a QA Associate for the CAR-T hub in Europe. The position will be based in Ghent Belgium.

CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T cells and are engineered to eliminate cancer cells expressing a specific antigen.

To support the CAR-T program in EMEA, J&J has built two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories are operating from the existing J&J Beerse site. CAR-T investigational medicinal and commercial CAR-T products are manufactured in the Ghent facilities.

In this role, you are reporting in the J&J QA CAR-T organization and work closely with your peers from Material Science and Technology, Operations and Quality Control.

The QA Associate will be responsible for ensuring that the manufacturing processes meet quality standards and regulatory requirements. The QA associate is responsible that product and process related investigations, complaints, batch review and release activities are properly handled on time and in line with all ATMP/GMP requirements. This role involves working closely with cross-functional teams, including Vein-to-Vein department, manufacturing and Regulatory affairs, to drive continuous improvement and support the development and commercialization of CAR T-cell therapies.

Major Responsibilities:

• Batch Documentation Review/Release : Review and approve batch documentation to verify compliance with regulatory and company standards. Release of incoming raw and starting materials and Final Drug Product release.
• Investigation Support : Provide technical, quality, and compliance expertise to support in-depth investigations related to deviations, complaints, and other quality issues to ensure timely resolution.
• Deviations and Complaints Management : Ensure that deviations and complaints are promptly and thoroughly investigated, with particular attention to those that may affect patient safety or product supply. Escalate issues that could have significant impacts on quality.
• CAPA Management : Ensure that appropriate corrective and preventive actions (CAPAs) are identified and implemented in response to investigations, especially those with potential impacts on product quality and patient safety.
• Inspection and Audit Support : Assist in the preparation, execution, and follow-up of internal and external inspections and audits to ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.
• Quality Oversight Participation : Contribute to the quality oversight programs by providing documented QA approval for GMP documentation and actively participating in quality review meetings to support operational activities.
• Collaboration and Stakeholder Engagement : Foster and maintain effective working relationships with internal teams, business partners, and external collaborators (e.g., Legend Biotech), ensuring alignment with quality objectives and deliverables.
• Flexibility in Working Hours : The position may involve flexible working hours, depending on project demands or business requirements.

Experience and Skills:

• Educational Background: A degree in Pharmacy or Bio-engineering is required. Certification as an Industrial Pharmacist is required (Qualified Person number).
• Experience: Minimum 3 years of cross-functional experience in the pharmaceutical industry.
• Pharmaceutical Knowledge: In-depth understanding of pharmaceutical product development, qualification, packaging, validation, testing, release, and distribution processes.
• Regulatory Knowledge: Up-to-date knowledge of pharmaceutical legislation, including current Good Manufacturing Practices (cGMP) and Advanced Therapy Medicinal Products (ATMP) regulations.
• Analytical and Decision-making Skills: Strong analytical thinking and decision-making abilities, with a keen attention to detail.
• Communication Skills: Excellent verbal and written communication skills to effectively negotiate and interact with both external and internal customers and partners.
• Quality Systems Experience: Proven experience working with quality systems, ensuring compliance with industry standards and regulatory requirements.
• Aseptic Processing Knowledge: Experience with aseptic processing and techniques is preferred, with a solid understanding of the requirements for sterile manufacturing.
• Organizational Skills: Highly organized, capable of managing multiple tasks in a team environment, and able to work effectively under minimal supervision while maintaining a positive attitude.
• Effective Communication: Strong communication skills, with the ability to convey technical and regulatory information clearly.

At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.

Preferred Skills:

Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards

The anticipated base pay range for this position is:

€60.000,00 - €96.255,00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.