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About the vacancy
Quality
Quality Assurance
Quality Assurance
About Your Next Job
- You will support quality investigations, quality risk management activities, inspection readiness, and compliance initiatives while working closely with cross-functional partners across the site.
- 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.
- Key responsibilities include providing timely and practical quality guidance on cGMP and quality-related topics, leading and supporting site investigations, supporting preparation activities for regulatory inspections (including FDA and EMA), reviewing deviation-related change controls, and assessing study protocols and reports.
About Your Next Colleagues
- You will work closely with Operations, Quality Control, Manufacturing, and other site functions.
- The role is part of the Quality Assurance team at Johnson & Johnson Innovative Medicine Biologics in Leiden, the Netherlands.
About Your Tasks and Responsibilities
- 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
About Your Skills and 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
About Your 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
- 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
- Service anniversary and recognition awards
- Employees - and in some location’s eligible dependents - can participate in several insurance plans
- The annual base pay includes an 8% holiday allowance
Where Molecules Meet Opportunities
- 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.
- 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.
Only apply if...
- 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
Contact person
Frank Helmus
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 https://www.jnj.com