Description
Johnson & Johnson is currently seeking a Quality Assurance Operational Commercial Products (QA-OCP) team at Johnson & Johnson Innovative Medicine Biologics Leiden .
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/.
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.
What you will be doing:
- 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
We would love to hear from you if you have the following 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.
What type of mark will YOU make?
By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well and your mind. When you work at Johnson & Johnson you can touch over a Billion lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything.
Diversity, Equity & Inclusion at Johnson & Johnson means "YOU belong"!
For more than 130 years, diversity, equity & inclusion 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 every one of our people feels that they belong and can reach their potential. No matter who they are.