Experienced Specialist QA

Biopharma Asia; Nederland; Hybrid; EUR 55,000 - 87,000; Full time

Job summary

Johnson & Johnson Innovative Medicine Biologics in Leiden, the Netherlands, seeks an Experienced QA Specialist to strengthen GMP compliance, product quality, and operational excellence in a pharma manufacturing setting.

You will partner with Operations, Quality Control, Manufacturing and other functions to ensure cGMP compliance, lead investigations, and support change controls and risk management in a dynamic environment.

Qualifications

• Bachelor's degree in Bioscience, Chemistry, Pharmacy, or related discipline with 4–6 years of relevant experience.
• Master's degree in Bioscience, Chemistry, Pharmacy, or related discipline with 2–4 years of relevant experience.
• Experience with GMP regulations and quality systems.

Responsibilities

• Provide timely and practical quality guidance on cGMP and quality-related topics.
• Lead site investigations and ensure CAPAs are implemented effectively within agreed timelines.
• Support preparation activities for regulatory inspections, including FDA and EMA inspections.
• Reviewing, assessing, and approving deviation-related change controls.
• Partner with site colleagues to ensure projects and changes comply with cGMP requirements.
• Assess and approve study protocols and reports, including validation and stability studies.
• Participate in Quality Risk Management activities and root cause investigations.
• Contribute to quality and compliance initiatives for continuous improvement across the organization.

Skills

Dutch & English communication

GMP knowledge

QA experience in pharma

Quality investigations & root cause

Lean tools & process excellence

Analytical problem solving

Cross-functional collaboration

AI concepts awareness

Education

Bachelor's degree in Bioscience, Chemistry or Pharmacy

Master's degree in Bioscience, Chemistry or Pharmacy

Job description

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Leiden, South Holland, Netherlands

Job Description:

e are searching for the best talent for an Experienced QA Specialist.

Purpose

We are looking for an Experienced QA Specialist to join the Quality Assurance team at Johnson & Johnson Innovative Medicine Biologics in Leiden, the Netherlands.

Are you interested in helping strengthen GMP compliance, product quality, and operational excellence within a dynamic pharmaceutical manufacturing environment?

The Quality Assurance department ensures that quality systems are applied in accordance with GMP requirements and supports activities such as non-conformance management, product release, change control, and compliance oversight. The team plays an important role in providing quality guidance across the supply chain and supporting the reliable delivery of products to patients.

In this role, you will support quality investigations, quality risk management activities, inspection readiness, and compliance initiatives while working closely with cross-functional partners across the site.

You will be responsible for

Working closely with Operations, Quality Control, Manufacturing, and other site functions, you will provide quality guidance on cGMP and quality‑related topics arising during routine and non‑routine operations.

The role includes participation in investigations, risk management activities, inspection readiness initiatives, and change management processes, while helping ensure compliance with company standards and regulatory requirements.

Key responsibilities include:

• Providing timely and practical quality guidance on cGMP and quality‑related topics


• Leading and supporting site investigations and helping ensure corrective and preventive actions (CAPAs) are implemented effectively within agreed timelines


• Supporting preparation activities for regulatory inspections, including FDA and EMA inspections


• Reviewing, assessing, and approving deviation‑related change controls


• Partnering with site colleagues to help ensure projects and changes are executed in compliance with cGMP requirements and company standards


• Assessing, reviewing, and approving study protocols and reports to help ensure activities are conducted in a controlled and compliant manner, including validation and stability studies


• Participating in Quality Risk Management activities and root cause investigation sessions


• Contributing to quality and compliance initiatives that support continuous improvement across the organization

This role offers the opportunity to work across multiple functions, contribute to compliance and quality initiatives, and help support the delivery of products that make a meaningful difference for patients.

Qualifications / Requirements

We are looking for someone who enjoys solving problems, working collaboratively, and contributing to quality and compliance within a regulated environment.

Education & Experience

• Bachelor's degree in Bioscience, Chemistry, Pharmacy, or a related scientific discipline with 4–6 years of relevant experience, or


• Master's degree in Bioscience, Chemistry, Pharmacy, or a related scientific discipline with 2–4 years of relevant experience

Knowledge & Skills

• Strong communication, collaboration, and advisory skills in Dutch and English, both written and verbal


• Up‑to‑date knowledge of GMP regulations and quality systems


• Experience in Quality Assurance within the pharmaceutical industry or a related regulated environment is preferred


• Experience with quality investigations, root cause analysis, and quality risk management


• Familiarity with Process Excellence, Lean tools, concepts, and methodologies is preferred


• Strong analytical and problem‑solving skills


• Ability to work effectively across teams and manage multiple priorities in a dynamic environment


• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity

What we offer

We offer a collaborative environment where learning, innovation, and professional development are encouraged.

In this role, you will have the opportunity to work with experienced colleagues, contribute to quality excellence, and help ensure products are manufactured and supplied in compliance with global quality standards.

Our commitment to inclusion

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation is powered by bringing together people with different backgrounds, experiences, and perspectives.

We are proud to be an equal opportunity employer and welcome applications from qualified candidates of all backgrounds.

If you require a reasonable accommodation during the application, interview, or onboarding process, support is available. Please let us know how we can help.

#LI-Hybrid

Required Skills:

• AI Judgement Integration, Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail‑Oriented, Goal Attainment, Human‑Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards

Preferred Skills:

• AI Judgement Integration, Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail‑Oriented, Goal Attainment, Human‑Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards

The anticipated base pay range for this position is:

€55000,00 - €86710,00

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.

Additional information:

The Netherlands: 8%.The annual base pay includes an 8% holiday allowance.

Het bruto jaarsalaris is inclusief vakantietoeslag van 8%.