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:
Business Enablement/SupportAll Job Posting Locations:
Leiden, 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
The Associate Specialist QA serves as a quality subject matter expert responsible for ensuring GMP compliance throughout the introduction and lifecycle management of products within the manufacturing environment. Working closely with Operations, Quality Control, Engineering, and Development teams, the role supports quality systems, batch release activities, documentation management, change control processes, and compliance initiatives. The Associate Specialist QA plays a critical role in maintaining product quality, supporting regulatory compliance, driving continuous improvement, and fostering a strong quality culture across the organization.
Key Responsibilities- Perform electronic batch record reviews and support batch disposition activities in accordance with GMP requirements.
- Review and release raw materials while maintaining accurate material master data within quality systems.
- Assess, approve, and verify change controls to ensure compliance and effective implementation of process changes.
- Review and approve GMP documents, including master batch records, validation reviews, and shipment-related documentation.
- Prepare release packages for Qualified Persons (QP) and support product release processes.
- Participate in local and global quality projects, support process optimization initiatives, and promote a culture of quality and compliance throughout the organization.
- Bachelor’s degree or higher in Biochemistry, Biology, Pharmacy, Life Sciences, or a related scientific discipline.
- Minimum of 2 years of experience in a GMP-regulated environment within Quality Assurance, Quality Control, Manufacturing, or a related pharmaceutical/biotechnology function.
- Strong understanding of GMP regulations, quality systems, batch release processes, change control, and compliance requirements.
- Experience within the biotechnology or pharmaceutical industry; knowledge of gene therapy and biological products is considered an advantage.
- Excellent analytical, problem-solving, and decision-making skills, with strong attention to detail and the ability to work independently.
- Strong communication, influencing, and stakeholder management skills, with excellent written and verbal English; Dutch language skills are 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:
Accountability, Administrative Support, Compliance Management, Detail-Oriented, Document Management, Execution Focus, Goal Attainment, Human-Centered Design, Internal Controls, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Report Writing
The anticipated base pay range for this position is:
€38.300,00 - €61.410,00Benefits:
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.
Skills Required
- Bachelor's degree or higher in Biochemistry, Biology, Pharmacy, Life Sciences, or a related scientific discipline
- Minimum of 2 years of experience in a GMP-regulated environment within Quality Assurance, Quality Control, Manufacturing, or a related pharmaceutical or biotechnology function
- Strong understanding of GMP regulations, quality systems, batch release processes, change control, and compliance requirements
- Experience within the biotechnology or pharmaceutical industry
- Excellent analytical, problem-solving, and decision-making skills
- Strong attention to detail and ability to work independently
- Strong communication, influencing, and stakeholder management skills
- Excellent written and verbal English
- Knowledge of gene therapy and biological products
- Dutch language skills
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
Johnson & Johnson Insights
What We Do
Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines
