QA Specialist

Location: Leiden, Netherlands 

Duration: Full Time/Contract 

Hours: 40 hours,

Imagine your next project enhancing the Quality Assurance Operational Commercial Products (QA-OCP) team, where your expertise will directly foster a high-quality organization within Johnson & Johnson Innovative Medicine Biologics Leiden.

Roles and Responsibilities

You will be an essential part of the Quality Assurance department, ensuring quality systems comply with GMP standards and providing crucial quality advice to all departments within the supply chain. This will involve:

• Providing timely and high-quality advice on cGMP (current Good Manufacturing Practice) and quality-related issues encountered during (non)routine operations.

• Leading all aspects of site investigations, ensuring that all Corrective and Preventive Actions (CAPAs) are implemented effectively and within agreed timelines.

• Assisting in the preparation for inspections (FDA, EMA, etc.) to ensure successful audit outcomes.

• Conducting assessments, reviews, and approvals of change controls related to commercial production and quality control testing.

• Partnering with site colleagues to ensure that all changes and projects are conducted in compliance with cGMP and company quality requirements.

• Assessing, reviewing, and approving study and validation protocols and reports to ensure that studies are conducted in a controlled and systematic manner in accordance with cGMP and regulatory requirements.

• Actively participating as a member in Quality Risk Management and root cause investigation sessions.

How to Succeed

We are looking for candidates who thrive on challenges, are solution-oriented, and appreciate the value of teamwork in a dynamic work environment. You will also bring:

• A Bachelor’s degree in bioscience, chemistry, pharmacy, or a related field, with 4-6 years of relevant experience; OR a Master’s degree in bioscience, chemistry, pharmacy, or a related field, with 2-4 years of relevant experience.

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

• Up-to-date knowledge of GMP regulations.

• Demonstrated experience with quality investigations, root cause problem-solving, and quality risk management.

• Preferably, experience in Quality Assurance within the pharmaceutical industry or a related field.

• Familiarity with PE (process excellence), LEAN tools, concepts, and methodologies is preferred.

Benefits

This role offers a very competitive hourly rate. This contract will run for a 12 month period

You Are Welcome Here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

About Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow. Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Application Process

We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.