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QA Release Specialist
At Legend Biotech, we are dedicated to transforming healthcare through advanced cell therapies. As a QA Release Specialist, you play a vital role in ensuring the quality and safety of our groundbreaking treatments. Join a passionate team committed to delivering impactful solutions that truly make a difference in patient’s lives.
Job
As a QA Release Specialist, you will ensure the quality of our personalized cell therapy products. You will work in a sterile, GMP-compliant environment to oversee batch records, improve processes, and support clinical and commercial operations.
Your responsibilities include:
Documentation and compliance
You ensure that all manufacturing activities comply with good documentation practices. You review paper and electronic batch records for clinical, development, and commercial production. You investigate non-conformances, implement corrective actions, and work proactively to reduce compliance issues. You perform tasks while adhering to safety policies, quality systems, and GMP requirements.
Collaboration and process improvement
You work closely with manufacturing teams to resolve batch record discrepancies and ensure compliance. You identify opportunities to improve batch record processes and reduce turnaround times to meet QA deadlines.
Profile
Education: You have a bachelor's degree in Science, Information Science, or a related technical field or you have equivalent experience.
Experience: You have at least 4 years of experience in a relevant role. If you have worked in aseptic manufacturing, quality assurance, or cell therapy, that is a great advantage.
Languages: You are fluent in Dutch and have a strong command of technical English.
Strengths: You have a sharp eye for detail and effortlessly stay organized, even in a faced-paced environment. Your strong communication skills help you build meaningful collaborations and tackle challenges with ease. When quick decisions are needed, you stay calm, process information swiftly, and make well-considered choices.
Expertise: You have a solid understanding of cGMP regulations, FDA/EU guidelines, and Good Tissue Practices. You're comfortable handling technical reports and compliance investigations.
Benefits
A meaningful job: Be part of a company with a clear mission - saving lives through groundbreaking cell therapies.
Work-life balance: Work in a shift schedule, including evenings and weekends, but enjoy a balance of four days on and four days off to recharge.
Supportive and inspiring work environment: Thrive in an inspiring workplace that sparks innovation and empowers continuous learning and personal growth. Here, a dynamic start-up mindset meets the financial stability of a Nasdaq-listed pharmaceutical leader.
Global perspective: Collaborate with colleagues worldwide.
Attractive benefits: A permanent contract with an attractive salary package and a wide range of benefits, including additional statutory vacations, meal vouchers, group and hospitalization insurance, double vacation pay, and an end-of-year and performance bonus.
Community spirit: Participate in informal events and activities that foster a vibrant and connected workplace culture.
Company profile
Legend Biotech is a global biotechnology company dedicated to developing, manufacturing and commercializing innovative and life-saving cell therapies, including treatments for hard-to-treat diseases like cancer.
Since our founding in 2014, we have expanded to over 2,000 employees across six global manufacturing facilities, with our headquarters in New Jersey.
In Ghent, we specialize in producing advanced CAR-T therapies for multiple myeloma, in partnership with Johnson & Johnson.
