Analyst Quality Assurance

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

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:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells which work by harnessing the power of a patients 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.

Heres what you can expect:

• Application review: Well carefully review your CV to see how your skills and experience align with the role.
• Getting to know you: If theres a good match youll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
• Final steps: For successful candidates you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

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 locations 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.