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QA Associate

Leiden, Netherlands; Sassenheim, Netherlands

Description

Project Pollux is the establishment of a new Janssen Supply Chain Lentiviral Vector (LVV) production facility in Sassenheim, the Netherlands, as part of Janssen Biologics B.V.

This Business Unit will become a key supplier for commercial LVV in support of the global Janssen BCMA CAR-T program for multiple myeloma, a disease affecting ~160,000 patients annually!

The Pollux business unit has been designed and has currently the following landmarks in the long-lead project plan:

  • Facility construction and building, and the Commissioning and Qualification of the facility, utilities, automation, and production equipment
  • Tech Transfer, introduction of process and product controls, producing PPQ batches, site approval, start routine production.

For this project we want to strengthen the Pollux Quality Department with a QA Specialist specifically to provide QA oversight over the completion of the Tech Transfer process, and start-up of the manufacturing process.

To be successful as a Quality Specialist, we need candidates who demonstrate strong communication skills, a risk-based mindset, ability to zoom out and in, and great attention to details. Ultimately, an outstanding leader who engages, is well organized and drives Quality decisions. It is an exciting opportunity to have an impact to the health of patients worldwide!

If that applies to you and you are interested, please keep reading !

Key Responsibilities :

  • You are a primary Quality contact in the Pollux project, specifically for Quality Processes related to the start-up of production. You ensure compliance with all regulatory requirements particularly in relation to the pharmaceutical industry, health and safety requirements and environmental legislation and cGMP requirements.
  • You set GMP standards and/or provide guidelines for the introduction of manufacturing processes, including the process controls, and the introduction of the materials and Single Use Systems.
  • You ensure that the manufacturing process and all its controls are set up in line with the regulations and the license.
  • You approve Change Controls and documentation, e.g., Work instructions and eBatch Records.
  • You review and approve non-conformance investigations.  You ensure appropriate corrective actions are implemented in a timely manner.
  • You raise serious quality, compliance and or GMP incidents to Departmental or Project Management.
  • You use Risk Management tools in your daily work and actively advocate the use of those tools in the rest of the project team. You support and approve Quality Risk Assessments
  • Explore opportunities to introduce emerging technological/digital solutions in Quality and drive these to implementation.
  • You actively take the lead in aligning requirements or expectations with our external (Quality) contacts in the LVV/CAR-T supply chain.
  • You enjoy working closely and effectively with colleagues at the Site and globally, on sharing Best Practices and exceeding Customer needs.

Qualifications

Education:

  • Proven experience in a Quality role in the biotechnical or pharmaceutical industry. A minimum of 4-6 years working experience in a GMP regulated environment.
  • Bachelor’s or higher degree in Biochemistry, Biology, Pharmaceuticals, or other relevant education.

Experience and Skills:

Required:

  • Excellent understanding and application of Global Regulatory (cGMp/ICH/FDA/EMA) guidelines.
  • Working knowledge on Large Molecule Manufacturing Processes
  • Independent problem solver in a complex environment, balancing business need, regulatory requirements, and cost efficiency for all Quality decisions.
  • Ability to drive teamwork in a fast-paced environment.
  • Connect easily at all levels in the organization and leads by example.
  • Embraces diversity and manages conflicting viewpoints.
  • Empowered professional who drives a Quality Mindset and can make well motivated pragmatic decisions on their own.

Preferred:

  • Experience in Tech Transfer and Risk Assessments have a strong preference.
  • Working knowledge of Eudralex Annex 2 is a must, knowledge of Annex 1 has an advantage.

Other:

  • Proficiency in English both in word and in writing.
  • Traveling is limited for the job, however, working on-site will be required when the work demands it.

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.

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