Experienced Specialist QA

Johnson & Johnson Co.; Amsterdam; On-site; EUR 55,000 - 87,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

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 pharmaceutical manufacturing setting.

You will work with Operations, Quality Control, and Manufacturing to provide quality guidance, investigations, risk management, and inspection readiness while ensuring compliance with company standards and regulatory requirements.

Qualifications

• Bachelor's degree or Master's with required years of experience in pharmaceutical QA.
• Experience in GMP and quality investigations is preferred.
• Fluent in Dutch and English, both written and spoken.

Responsibilities

• Providing timely quality guidance on cGMP topics.
• Leading site investigations and CAPA implementation.
• Supporting regulatory inspection preparations (FDA/EMA).
• Reviewing deviation-related change controls.
• Collaborating with site colleagues to ensure compliance.
• Reviewing study protocols and reports including validation/stability.
• Participating in Quality Risk Management and continuous improvement.

Skills

GMP regulations

Quality Assurance

Quality investigations

Root cause analysis

Process Excellence / Lean

Analytical & problem solving

Cross-functional collaboration

AI awareness

Education

Bachelor's degree in Bioscience/ Chemistry/ Pharmacy

Master's degree in Bioscience/ Chemistry/ Pharmacy

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

We 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

• 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

Qualifications / Requirements

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 opportunities 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 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 https://www.jnj.com/. Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive. Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities. If you need support at any stage of the recruitment process, please complete our candidate accommodation request form so we can assist you.

The anticipated base pay range for this position is: €55 000,00 - €86 710,00

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
• 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
• service anniversary and recognition awards
• several insurance plans for employees and in some location’s eligible dependents
• *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%

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