Quality Assurance Specialist

At Johnson & Johnson, we believe health is everything. 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. 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: Leiden, South Holland, Netherlands Job Description: About Innovative Medicine    Our expertise in 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  We are searching for the best talent for the Quality Assurance Specialist to be based in Leiden . Join our QA Operational Commercial Products (QA‑OCP) team at Johnson & Johnson Innovative Medicine Biologics Leiden to help ensure site and supply chain activities meet cGMP standards, support regulatory readiness, and protect product quality and patient safety. You’ll work closely with colleagues across the site to solve quality challenges and drive improvements—fluency in Dutch and English is required! You will be responsible for: Provide timely, practical cGMP and quality advice during routine and non-routine operations to maintain compliance and keep site activities on track. Lead end-to-end site investigations and drive CAPA implementation to prevent recurrence and improve site performance. Prepare for and support regulatory inspections (e.g., FDA, EMA) to maintain inspection readiness and support successful audit outcomes. Review, assess, and approve change controls for commercial production and quality control testing to ensure compliant, well-documented changes. Evaluate and approve study and validation protocols and reports so studies run in a controlled, systematic, and compliant way. Collaborate with site colleagues in quality risk management and root cause analysis to identify risks and deliver continuous improvement. Qualifications/Requirements: Bachelor’s degree in bioscience, chemistry, pharmacy, or a related field with 4–6 years’ relevant experience, OR a Master’s degree in a related field with 2–4 years’ relevant experience. Preferable experience working in Quality Assurance within the pharmaceutical industry or a related field. Demonstrated experience leading quality investigations, conducting root cause analysis, and managing CAPAs. Up-to-date knowledge of cGMP and applicable regulatory expectations. Strong communication, collaboration, and advisory skills in both Dutch and English, verbal and written. Familiarity with Process Excellence (PE), LEAN tools, concepts, or similar process improvement methods is preferred. 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. Here’s what you can expect: Application review: We’ll carefully review your CV to see how your skills and experience align with the role. Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you