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Product Quality Integrator

Vacaturenummer: A2100214
Janssen Vaccines & Prevention - Leiden (Nederland)

For our client, Janssen Vaccines & Prevention, we are looking for a Product Quality Integrator.

Keywords

  • cGMP
  • Quality systems
  • Manufacturing
  • Pharmaceutical products


Profile
Do you want to contribute to the development and introduction of much needed vaccines? As Product Quality Integrator (PQI), you have end-to-end accountability for the quality strategy and quality aspects from Early Development through commercialisation for an assigned group of product(s) in the Vaccines Therapeutic Area.
Main responsibilities:
  • 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.;
  • 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);
  • 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.


Who we're looking for
The ideal candidate has an M.Sc. in Pharmacy, Biology, Biochemistry, Biotechnology, Engineering, or Life Sciences with at least 5 years of experience in pharmaceutical and/or biotechnology industry. You have proven knowledge in cGMP standards, policies and procedures.
We prefer candidates that have knowledge of and/or have worked in the following areas: biotechnology, vaccines, API manufacturing, sterile pharmaceutical manufacturing, process development, technology transfer, process validation, developing quality modules of regulatory filings.
You have demonstrated knowledge of and/or experience in quality systems and processes, e.g., change control, deviation handling, CAPA, risk management, complaints handling, (regulatory) inspections, and manufacturing control strategies.
You use analytical skills to drive creative solutions that strike a good balance between quality requirements and business needs. Working with diverse teams, you build relations and partnerships that allow you to influence decision making.


Company profile
Janssen Vaccines & Prevention B.V. is part of Johnson & Johnson, one of the biggest and most respected health care companies in the world. They are dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacturing, and marketing of novel vaccines to prevent some of the most devastating and complex infectious diseases. These range from respiratory infections like respiratory syncytial virus (RSV) to human immunodeficiency virus (HIV) and pathogens of global concern, such as Ebola and COVID-19.
In this organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are of crucial importance. They are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen. The offices of Janssen Vaccines & Prevention are located in Leiden, The Netherlands.



Additional vacancy information
Reference:A2100214
Contract:Direct contract with client
Education:WO/MSc.
Employment terms:Salary:75.000 - 100.000
Days of leave: 36
Flexible hours to accommodate US, EMEA and ASPAC work schedules when necessary.
May require up to 10% domestic and international travel as business demands.
Publication date:19-10-2021
Location:View location with Google Maps
Contactperson:Claudia Erwich-Faaij
+31 (0)88 22 77 555

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.