Associate Specialist Quality Assurance

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: Business Enablement/Support All Job Posting Locations: Leiden, 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   Job Description The Associate Specialist QA serves as a quality subject matter expert responsible for ensuring GMP compliance throughout the introduction and lifecycle management of products within the manufacturing environment. Working closely with Operations, Quality Control, Engineering, and Development teams, the role supports quality systems, batch release activities, documentation management, change control processes, and compliance initiatives. The Associate Specialist QA plays a critical role in maintaining product quality, supporting regulatory compliance, driving continuous improvement, and fostering a strong quality culture across the organization.

Perform electronic batch record reviews and support batch disposition activities in accordance with GMP requirements. Review and release raw materials while maintaining accurate material master data within quality systems. Assess, approve, and verify change controls to ensure compliance and effective implementation of process changes. Review and approve GMP documents, including master batch records, validation reviews, and shipment-related documentation. Prepare release packages for Qualified Persons (QP) and support product release processes. Participate in local and global quality projects, support process optimization initiatives, and promote a culture of quality and compliance throughout the organization.

Bachelor’s degree or higher in Biochemistry, Biology, Pharmacy, Life Sciences, or a related scientific discipline. Minimum of 2 years of experience in a GMP-regulated environment within Quality Assurance, Quality Control, Manufacturing, or a related pharmaceutical/biotechnology function. Strong understanding of GMP regulations, quality systems, batch release processes, change control, and compliance requirements. Experience within the biotechnology or pharmaceutical industry; knowledge of gene therapy and biological products is considered an advantage. Excellent analytical, problem-solving, and decision-making skills, with strong attention to detail and the ability to work independently. Strong communication, influencing, and stakeholder management skills, with excellent written and verbal English; Dutch language skills are a plus. 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