Johnson & Johnson Careers
Sr QA Associate
Requisition ID: 1805679553W
Janssen Vaccines & Prevention, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. Our teams focus on the discovery, development, manufacture and marketing of vaccines and antibodies to protect people worldwide from infectious diseases.
In our organization entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen.
For our Quality Department, we are looking for new talent. Should you recognize yourself in the information below, please connect by applying
Quality Assurance at Janssen Vaccines & Prevention in Leiden is a fast-developing department. Janssen Vaccines & Prevention is currently working on a full Vaccine pipeline, developed at our site in Leiden and by external collaborations. The QA Group is responsible for overseeing and supporting the quality systems, projects and facilities. The opportunities and responsibility for the Quality Assurance department to shape and deliver the right quality are key for the success of Janssen Vaccines & Prevention. The group is forward looking, working on improving processes, being customer focused and supports the need for speed. The team is most successful with employees that are proactive and are willing to take ownership, collaborate and are enthusiastic to work in an innovative and focused environment.
We are looking for a Senior QA Associate who enjoys working in multidisciplinary teams. As Senior QA Associate you will work across multiple projects and sites throughout our pipeline to ensure Quality Oversight on manufacturing and development activities from early development up to late phase development including process validation. . The scope of responsibilities includes both drug substance and drug product manufacturing QA oversight. You will be pioneering new oversight models assuring compliance with regulatory requirements and internal Johnson and Johnson procedures bringing this to fruition by working together locally and with global organizational arms of the enterprise. As part of the QA oversight you will be involved as lead GMP auditor in internal and external auditing and you will act as a point of contact for both internal and external business partners and contractors, You will be handling a high complexity of quality issues and changes on both content and process topics. Your expertise will be required to tackle challenges in with many backgrounds, including analytical, manufacturing and qualification.
We offer a challenging position which allows you to work on different types of interesting products in various stages of development in a group with a large span of control. You will work in a matrix structure in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development.
M.Sc. in a relevant discipline such as Bio-Pharmaceutical Sciences or Pharmacy. Solid knowledge and training in GMP and QA is required, coming from at least 8 years of relevant work experience, working in all phases of product development. Experience with Sterile manufacturing and Vaccines is highly valued.
The candidate fit for the job is pro-active, agile, and enjoys working in a team. Affinity with GMP, procedure and process optimization and batch preparation and release are required. Excellent writing and communication skills, a no-nonsense mentality and a strong process-oriented mindset are key for this position. Excels in conceptual thinking and the implementation of ideas. The candidate is able to drive change in a complex stakeholder environment and to think and challenge beyond their own expertise area. Strategic vision required. For the function of Senior QA Associate we are looking for the competences related to a lead GMP auditor.
As an employee, we consider you as our most valuable asset.
We take your career seriously. As part of a global team in an
innovative environment, your development is key and our day-to-day responsibility. Through courses, on the job training, various projects and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future.
Janssen Vaccines & Prevention BV (8852)