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About the vacancy
Quality
Quality Assurance
Quality Assurance
About Your Next Job
- You will lead a team of QA specialists responsible for quality oversight of commercial manufacturing and its supporting digital systems at our Leiden site.
- You will be part of the QA-OCP management team and will work in close collaboration with other departments (Operations, warehouse, QC labs, maintenance and MSAT).
- You will provide quality leadership and governance for digital and computerized systems supporting commercial operations, including Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES), business intelligence solutions, computerized system validation, and qualification.
About Your Next Colleagues
- You will be part of the QA-OCP management team.
- You will work in close collaboration with other departments: Operations, warehouse, QC labs, maintenance and MSAT.
About Your Tasks and Responsibilities
- Lead, coach, and develop a team of 8–12 QA specialists.
- Serve as the primary QA partner for Operations, Warehouse, QC Laboratories, Maintenance, and MSAT.
- Lead the resolution and escalation of complex quality and compliance issues.
- Maintain and improve GMP processes supporting commercial manufacturing and testing.
- Provide quality oversight for digital and computerized systems.
- Support inspection readiness programs and manage the process during Regulatory inspections.
About Your Skills and Experience
- Master’s degree in a relevant scientific or technical discipline, such as biosciences, pharmacy, analytical chemistry, process technology, or engineering.
- Minimum of six years’ experience in quality and/or similar GMP environment in pharmaceutical, consumer or medical device company, of which minimum two years in a managerial, people leading role.
- Strong quality mindset, sound risk-based judgment, and the ability to make and defend well-reasoned quality decisions.
- Knowledge of current Quality Management principles, cGMP requirements and Quality Systems Pharma regulations (ICH, FDA and EMA).
- Knowledge of digitalization, Business Intelligence, ERP systems, MES systems, computerized system validation and qualification.
- Perfect written and oral communication skills in Dutch and English.
- Team player, and ready to take a stand when necessary.
- Demonstrate an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and experience generating effective prompts to boost efficiency and productivity.
About Your Benefits
- Flexible working arrangements.
- Your chance to be part of a global market leader.
- A dynamic and inspiring working environment.
- The opportunity to establish and lead a new team within the Quality organization.
- Exposure to current and future biopharmaceutical manufacturing technologies.
- Access to an international network of quality and digital-system experts.
- Opportunities for continuous professional development.
- 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.
- Subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.
Where Molecules Meet Opportunities
- Johnson & Johnson Innovative Medicine develops and manufactures innovative medicines for patients worldwide.
- At our Leiden site, Quality Assurance provides independent GMP oversight across manufacturing, laboratory, warehouse, maintenance, and supporting quality-system activities.
- 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...
- Master’s degree in a relevant scientific or technical discipline, such as biosciences, pharmacy, analytical chemistry, process technology, or engineering.
- Minimum of six years’ experience in quality and/or similar GMP environment in pharmaceutical, consumer or medical device company, of which minimum two years in a managerial, people leading role.
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