Manager QP Quality Assurance

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 looking for an enthusiastic and motivated colleague who will help us to strengthen our QA team of Johnson & Johnson Innovative Medicine (JJIM) in Leiden, The Netherlands. Somebody who would like to contribute to a high-quality organization of the site and J&J. The Manager/QP will be be the linking pin in the investigations into quality issues and with that will be responsible for the improvement of the overall quality status of the site. You will be part of the QA operational commercial product management team and will work in close collaboration with other departments (Operations, warehouse, QC labs, MAM and Technical Operations). The position provides a unique opportunity to work on the latest and future technologies in biopharmaceutical manufacturing, and you will become part of a worldwide network of QA experts within and beyond J&J. The activities are very dynamic and varied. The candidate likes challenges, doesn’t avoid problems and enjoys working in various teams.

JJIM is a multinational pharmaceutical company that has been for more than 25 years a leader in the field of biomedicines. Through the dynamic science of biotechnology, we continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders, such as rheumatoid arthritis and psoriasis. JJIM is part of the Johnson & Johnson family of companies. The department Quality Assurance sees to that quality systems are applied as per GMP standards and is responsible for handling non-conformances, bulk (PFB / FB) and intermediate (DPC / CSS) release and change control. In addition, the department is responsible for providing quality oversight and support during daily operations activities. With that, the QA department plays a significant role in providing advice on quality topics to all departments of the supply chain. We are looking for an enthusiastic and driven colleague who can take up this challenging role as Manager QA. The responsibilities & the impact YOU will have: The manager/QP leads a team of 6-10 QA specialists Manages, leads & motivates the QA OCP department and its people to enhance performance and achieve business goals, agreed metrics & budgets Act as Qualified Person for Large Molecule products Ensure that in a timely manner a clear and quality prospected advice is given to all cGMP and/or quality related issues encountered during (non)routine operations. Lead all aspects of complex site investigations and ensure that all CAPAs are implemented and effective within agreed timelines. Manages the resolution of unexpected complex quality or compliance issues across the whole site (where needed) Manages and improves the GMP processes to facilitate the production and testing of Commercial products at JJIM Influences and manages regulatory and corporate expectations and relationships to ensure alignment of the site’s quality systems, projects and programs to