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 https://www.jnj.com/
J&J Innovative Medicine is recruiting for an Experienced Specialist QA (1 year fixed-term contract) reporting to the QA Manager and to be located in Leiden, Netherlands.
We are seeking an enthusiastic and highly motivated colleague to enhance our Quality Assurance Operational Commercial Products (QA-OCP) team at Johnson & Johnson Innovative Medicine Biologics Leiden. This role is essential for fostering a high-quality organization on the site and within J&J.
Department: The Quality Assurance department plays a critical role in ensuring that quality systems comply with GMP (Good Manufacturing Practice) standards within J&J Innovative Medicine. The team is responsible for managing non-conformances, bulk product and intermediate product releases, and change control, while providing quality advice to all departments within the supply chain.
Responsibilities:
- Provide timely and high-quality advice on cGMP (current Good Manufacturing Practice) and quality-related issues encountered during (non)routine operations.
- Lead all aspects of site investigations, ensuring that all Corrective and Preventive Actions (CAPAs) are implemented effectively and within agreed timelines.
- Assist in the preparation for inspections (FDA, EMA, etc.) to ensure successful audit outcomes.
- Conduct assessments, reviews, and approvals of change controls related to commercial production and quality control testing.
- Partner with site colleagues to ensure that all changes and projects are conducted in compliance with cGMP and company quality requirements.
- Assess, review, and approve 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 participate as a member in Quality Risk Management and root cause investigation sessions.
Qualifications
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.
Essential Requirements:
- Strong communication, collaboration, and advisory skills in both Dutch and English (verbal and written).
- Up-to-date knowledge of GMP regulations.
- Preferably, experience in Quality Assurance within the pharmaceutical industry or a related field.
- Demonstrated experience with quality investigations, root cause problem-solving, and quality risk management.
- Familiarity with PE (process excellence), LEAN tools, concepts, and methodologies is preferred.
Eligibility for the experienced specialist QA role is dependent on the level of relevant experience, which will be assessed during the job application process.
Key Attributes: We are looking for candidates who thrive on challenges, are solution-oriented, and appreciate the value of teamwork in a dynamic work environment. If you possess the qualifications and passion for quality assurance, we encourage you to apply!
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong