Experienced Specialist QA

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.

We are looking for an Experienced QA Specialist to join the Quality Assurance team at Johnson & Johnson Innovative Medicine Biologics in Leiden, the Netherlands.

Are you interested in helping strengthen GMP compliance, product quality, and operational excellence within a dynamic pharmaceutical manufacturing environment?

The Quality Assurance department ensures that quality systems are applied in accordance with GMP requirements and supports activities such as non-conformance management, product release, change control, and compliance oversight. The team plays an important role in providing quality guidance across the supply chain and supporting the reliable delivery of products to patients.

In this role, you will support quality investigations, quality risk management activities, inspection readiness, and compliance initiatives while working closely with cross-functional partners across the site.

Working closely with Operations, Quality Control, Manufacturing, and other site functions, you will provide quality guidance on cGMP and quality-related topics arising during routine and non-routine operations.

The role includes participation in investigations, risk management activities, inspection readiness initiatives, and change management processes, while helping ensure compliance with company standards and regulatory requirements.

• →Providing timely and practical quality guidance on cGMP and quality-related topics
• →Leading and supporting site investigations and helping ensure corrective and preventive actions (CAPAs) are implemented effectively within agreed timelines
• →Supporting preparation activities for regulatory inspections, including FDA and EMA inspections
• →Reviewing, assessing, and approving deviation-related change controls
• →Partnering with site colleagues to help ensure projects and changes are executed in compliance with cGMP requirements and company standards
• →Assessing, reviewing, and approving study protocols and reports to help ensure activities are conducted in a controlled and compliant manner, including validation and stability studies
• →Participating in Quality Risk Management activities and root cause investigation sessions
• →Contributing to quality and compliance initiatives that support continuous improvement across the organization

This role offers the opportunity to work across multiple functions, contribute to compliance and quality initiatives, and help support the delivery of products that make a meaningful difference for patients.

We are looking for someone who enjoys solving problems, working collaboratively, and contributing to quality and compliance within a regulated environment.

• Bachelor's degree in Bioscience, Chemistry, Pharmacy, or a related scientific discipline with 4–6 years of relevant experience, or
• Master's degree in Bioscience, Chemistry, Pharmacy, or a related scientific discipline with 2–4 years of relevant experience

• Strong communication, collaboration, and advisory skills in Dutch and English, both written and verbal
• Up-to-date knowledge of GMP regulations and quality systems
• Experience in Quality Assurance within the pharmaceutical industry or a related regulated environment is preferred
• Experience with quality investigations, root cause analysis, and quality risk management
• Familiarity with Process Excellence, Lean tools, concepts, and methodologies is preferred
• Strong analytical and problem-solving skills
• Ability to work effectively across teams and manage multiple priorities in a dynamic environment
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation is powered by bringing together people with different backgrounds, experiences, and perspectives.

We are proud to be an equal opportunity employer and welcome applications from qualified candidates of all backgrounds.

If you require a reasonable accommodation during the application, interview, or onboarding process, support is available. Please let us know how we can help.

The Netherlands: 8%.The annual base pay includes an 8% holiday allowance.

Het bruto jaarsalaris is inclusief vakantietoeslag van 8%.