Quality Assurance Specialist

7266-Janssen Biologics B.V. Legal Entity; Amsterdam; On-site; EUR 45,000 - 71,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being programs

Job summary

Johnson & Johnson Innovative Medicine Biologics Leiden seeks a Quality Assurance Specialist to ensure site and supply chain activities meet cGMP standards and support regulatory readiness. You will collaborate with cross-site colleagues and require fluency in Dutch and English.

The role focuses on quality investigations, CAPA, change controls, and ensuring compliant documentation for commercial production and QA testing, with strong emphasis on site improvement and regulatory readiness.

Qualifications

• Bachelor’s degree in bioscience, chemistry, pharmacy, or related field with 4–6 years’ experience or Master’s with 2–4 years’ experience.
• Experience in Quality Assurance within pharma or related field preferred.
• Knowledge of cGMP and regulatory expectations is required.

Responsibilities

• Provide cGMP and quality advice to maintain compliance during operations.
• Lead end-to-end site investigations and CAPA implementations.
• Prepare for and support regulatory inspections (FDA, EMA).
• Review and approve change controls for commercial production and QA testing.
• Evaluate and approve study/validation protocols and reports.
• Collaborate on quality risk management and root cause analysis for continuous improvement.

Skills

Communication skills

Dutch-English bilingual

Advisory skills

Education

Bachelor’s degree in bioscience/chemistry/pharmacy

Master’s degree in related field

Tools

LEAN tools

Job description

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.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is: €44,700.00 - €70,840.00

In addition to base pay, we offer the following 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. Moreover, we offer 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. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers. *This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.