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:
QualityJob Sub Function:
Quality AssuranceJob Category:
ProfessionalAll Job Posting Locations:
Leiden, Netherlands, Sassenheim, NetherlandsJob 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
Role Overview
The Specialist Quality Assurance acts as a quality expert supporting the implementation and execution of Quality Systems to enable the successful introduction and manufacture of new biotherapeutic products. The role ensures compliance with cGMP, global regulatory requirements, and company policies by working cross‑functionally with Operations, QC, Engineering, Planning, and Development. Through independent judgment and subject‑matter expertise, the Specialist QA contributes to a strong quality culture while enabling the consistent delivery of safe, compliant, and high‑quality products.
Key Responsibilities:
Implement and maintain Quality Systems including validation, change control, batch record review, and batch release for new and existing products
- Review, prepare, and approve GMP documentation such as validation reviews, method transfer protocols, MES master batch records, material master changes, and change controls
- Perform batch record review and prepare release documentation for raw materials, intermediates, and bulk products
- Act as deputy process owner and subject matter expert for raw material release and WCB/DS/DPC release processes
- Ensure quality systems are compliant, effective, and continuously optimized across the organization
- Serve as a QA representative and subject matter expert during internal and external audits and regulatory inspections
- Deputize for the QA Manager as required, including approval of QA documentation and oversight of key quality processes
Requirements:
- Bachelor’s degree or higher in Biochemistry, Biology, Pharmacy, or a related scientific discipline
- Minimum of 2 years (MSc) or 4 years (BSc) experience in Quality or regulated supply chain operations
- Strong knowledge of biotechnological or pharmaceutical manufacturing and global regulatory guidelines (cGMP, ICH, FDA, EMA)
- Proven analytical, problem‑solving, and risk‑based decision‑making skills with high attention to detail
- Ability to work independently, prioritize effectively, and manage complex or conflicting stakeholder requirements
- Strong communication, influence, and collaboration skills in cross‑functional environments
- Fluent in written and spoken English; knowledge of Dutch and experience in vaccines are considered 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 see how your skills and experience align with the role.
Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.
Finally, at the end of the process, we’ll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process! #RPOEMEA
Required Skills:
Preferred Skills:
