Experienced Specialist QA AT

Janssen Biologics is working on the establishment of a new Lentiviral Vector (LVV) production facility in Sassenheim, the Netherlands, as part of the Advanced Therapy (AT) Supply Chain of J&J.

This LVV 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 LVV BU is currently in the Tech Transfer, finalizing qualifications, and getting ready for PPQ batches and regulatory site approval, and then starting routine production.

For the support of this facility, we want to strengthen the QA AT Quality Department with an Experienced 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 Exp.

Specialist Quality, 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 one of the primary Quality contacts in the LVV BU, 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 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 review and approve Change Controls and documentation, e.g., Work instructions and eBatch Records.


* You assess, review and approve study protocols and reports to assure that studies will be executed in a controlled and systematic manner conform cGMP and regulatory requirements e.g.

but not limited to stability, validation.


* 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.


* Assist in the preparations for and during inspections (FDA, EMA etc.) to accomplish a successful audit.


* You actively take the lead in aligning requi...