Biotech and Agricultural Engineering IT Management & Business Others Medical and Healthcare Other Science and Tech
3 - 5 Years
Project Manager Quality Control (Yacht Life Sciences)
Janssen Biologics B.V. is a multinational pharmaceutical company that has been for more than 25 years a leader in the field of biomedicine. 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 (I.M.I.D.s), such as rheumatoid arthritis and psoriasis. Janssen Biologics Leiden Operations delivers key commercial Biotherapeutic products (API) like Remicade, Simponi, and Stelara. Janssen Biologics is part of the Johnson & Johnson family of companies.
Yacht Life Sciences has a vacancy for a Project Manager Quality Control (QC) at Janssen Biologics in Leiden.
We are searching for a suitable candidate to manage the release and stability testing for the Ebola vaccine. In your role, you will be accountable for the external laboratories (QC testing and NCL) which will test the Ebola vaccine.
As a Project Manager QC, you will combine your experience in Quality Control testing with your talent for keeping clear overviews. You need coordination skills to maintain the current processes and you should work together with other parties like External Manufacturing and Procurement to ensure all required assets are in place to enable efficient outsourcing and testing of the Ebola vaccine. You will work closely together with the COVID-19 test team (leveraging their network and expertise), the COVID-19 NCL team (leveraging their network and expertise), the External Quality group (keeping oversight on the ECL´s), the Analytical development department (making sure all assays are transferred and qualified) as well as with the QA department of different manufacturing sites. You will be responsible to ensure timely testing of the products.
Your main tasks and responsibilities as a Project Manager QC will be:
Keep clear overviews of different business processes
Set up and maintain planning and reporting tools
Ensure financial flows are managed
Ensure a standard process with standard governance structures is set up and maintained with the external laboratories
Independently solve issues (including QI management) as well as solving issues with key stakeholders like Subject matter experts from analytical development or manufacturing
Manage all systems, including data management to be utilized to ensure test results are accessible in time for release and stability
Ensure timely and proper reporting to partners and stakeholders
Bachelor or Master degree
>8 years relevant experience in a pharmaceutical environment and good knowledge of GMP
Experience working in Pharma Quality Control or Analytical Development laboratories
Experience in a Quality Assurance or Compliance related function
Experience with NCL testing preferred
Lead auditor qualification preferred
Project management experience
Experience with laboratory management systems (LIMS)
Knowledge about the outsourcing process within a pharmaceutical company is advantageous
Professional proficiency in English
We offer a challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development. This concerns a full-time (40h) secondment contract via Yacht for 1 year (extension is possible). This is a 80% remote job, 20% onsite.
We will offer a competitive benefits package in line with the seniority of the position (salary between 4500 and 5800 euro gross per month). You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.