For this project, they want to strengthen the Pollux Quality Team with a Senior QA Specialist, specifically to provide QA oversight over the Qualification of facility, utilities, automation, and production equipment.
To be successful as a (Sr) 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 organised 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.
- You are a primary Quality contact in the Pollux project, in your area of expertise. 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 commissioning and qualification, e.g., in master validation programs, leveraging, out of place qualifications, family approach etc., in line with regulations. You are skilled in Data Integrity requirements and in CSV;
- You do the Quality review and approval of all related GMP documentation from a QA perspective, e.g., qualification protocols and reports, Automation documentations, electronic Master Batch Records/MES, Operational SOPs etc.;
- You ensure that learnings from C&Q are translated into proper controls in the SOPs and Work Instruction for operations, maintenance, or other processes;
- 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 review and approve non-conformance investigations in your area of expertise. You ensure appropriate corrective actions are implemented in a timely manner;
- You raise serious quality, compliance and or GMP incidents to Department or Project Management;
- 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.
Who we're looking for
The ideal candidate has at least a B.Sc. in Engineering, with at least 4-8 years of experience in a GMP regulated environment. Additionally, you have proven experience in a Quality role in the biotechnical or pharmaceutical industry. Working knowledge of Eudralex Annex 1 is highly advantageous.
Other required skills:
- Excellent understanding and application of Global Regulatory (cGMp/ICH/FDA/EMA) guidelines;
- 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 organisation 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.
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, producing validation batches, site approval, start routine production.
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.
They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.
Additional vacancy information
CLS Services is a leading professional recruitment agency, specialised in the recruitment and secondment of people with a background in chemistry & life sciences.
|Contract||:||Temporary contract with CLS Services|
|Employment terms||:||Project for at least 9 months.|
Traveling is limited for the job, however, working on-site will be required when the work demands it.
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|