Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Product Quality Integrator, Launch & Grow Biotherapeutics. The position is linked to the Janssen Vaccines & Prevention organization, which is based in Leiden, the Netherlands.
The PQI has end-to-end accountability for the quality strategy and quality aspects from Early Development through commercialization for an assigned group of product(s) in the Vaccines Therapeutic Area.
We are looking for candidates that want to contribute to the development and introduction of much needed vaccines, especially in these times of the Covid-19 pandemic.Main responsibilities:
You represent Global Quality on the Chemistry, Manufacturing, and Controls (CMC) and Value Chain (VCT) Teams.
With the Quality sub-team, that you lead, we ensure that Quality (stage gates) results are achieved in a timely manner and that the necessary resources are made available to perform all activities. We use standard Quality processes across all sites involved, including New Product Introduction, technology transfer, risk management, process validation, etc.
You act as Quality reviewer for health authority submissions, i.e., IND, IMPD, BLA, NDA, and MAA. You also support Pre-Approval Inspections and other health authority audits for your product(s).
Finally, you provide support to the program(s) by actively participating in, for example, significant manufacturing issues related to product quality, the handling of product quality complaints, safety management teams, definition and renewal of Product Strategy Roadmaps, and projects related Business Continuity Planning.
In all activities, we are expected to bring creative solutions to define a solid quality strategy with flexibility for business needs, thus providing the best total value to the company.What we are looking for is:
Education and experience:
Flexible hours to accommodate US, EMEA and ASPAC work schedules when necessary, balancing work and personal time is required.
This position will be linked to the Janssen Vaccines & Prevention organization, which is based in Leiden, the Netherlands, and may require up to 10% domestic and international travel as business demands.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.Primary Location