Associate Specialist Quality Assurance

Johnson & Johnson Innovative Medicine; Leiden; On-site; EUR 38,000 - 61,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Job summary

Johnson & Johnson Innovative Medicine in Leiden seeks an Associate Specialist QA to ensure GMP compliance throughout product lifecycle in manufacturing. You will work with Operations, Quality Control, Engineering and Development to support quality systems, batch release, documentation, change control and regulatory initiatives.

You will review batch records, release materials, manage change controls, prepare release packs for Qualified Persons, and participate in global quality projects to drive

Qualifications

• 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.

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.

Skills

Communication

Stakeholder mgmt

English proficiency

Attention to detail

Education

Bachelor’s degree in Biochemistry, Biology, Pharmacy, Life Sciences

Job description

All Job Posting Locations:
Leiden, Netherlands

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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:

Business Enablement/Support

All Job Posting Locations:

Leiden, 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

Job Description

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.

Requirements

• 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 - €61.410,00

Benefits:

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.