Quality Assurance Associate

Imagine your next role as a Quality Assurance Associate with Lab experience and experience in setting up a Lab/experience with new equipment.

About the project 

Project Pollux is the establishment of a new Janssen Supply Chain Lentiviral Vector (LVV) production facility in Sassenheim, the Netherlands, to be organized as a new business unit for Janssen Biologics B.V. Additionally Release and Stability Testing capacity is created in Leiden, to support the new manufacturing facility.

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:

• Laboratory Design, Lab Equipment Qualification, and Test Methods Transfer

• Facility and production equipment commissioning and qualification

• Tech Transfer, producing validation batches, site approval, start routine production.

The Quality Department is a dedicated team of enthusiastic and skilled Quality professionals with various technical expertise and backgrounds.

We are looking for a committed individual to strengthen our Pollux Quality team as a Quality Associate. The main responsibility of the (Sr) Quality Specialist is to provide Quality Oversight over all aspects of the project, with a focus on ensuring that the new Laboratory is fit for use and meets all cGMP (and Biosafety Level) requirements. The job can also include supporting the manufacturing facility, as needed

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

roles and responsibilities

• You are a primary Quality contact in the Pollux project.

• You ensure compliance with all regulatory requirements particularly in relation to the pharmaceutical industry, health and safety requirements and environmental legislation, and cGMP requirements.

• Set GMP standards and/or proactively provide guidelines for GMP processes, Laboratory Design, Lab Equipment Qualifications, Test Method Transfer strategy, and lab operational readiness.

• Quality review and approval of Change Controls, Qualification documentation, Standard Operating Procedures, etc.

• Assist or take the lead in Quality Risk Assessments and ensure that adequate mitigations are implemented in a timely manner.

• Assist or take the lead in aligning processes with our external (Quality) contacts in the LVV/CAR-T supply chain

• Assist or take the lead in outlining Quality Documentation that needs to be written or revised to ensure that Laboratories are GMP-ready, e.g., Quality Agreements, Quality SOP’S etc.

• Set up the Inspection Readiness program for the Labs and acts as a Quality expert for regulatory submissions and inspections.

• Explore opportunities to introduce emerging technological/digital solutions in Quality and drive these to implementation.

• Support and approve non-conformance investigations and appropriate corrective/preventive action plans, and ensure actions are implemented timely. You raise serious quality, compliance, and or GMP incidents to Department or Project / Site Management.

• You enjoy working closely and effectively with colleagues at the Site and globally, on sharing Best Practices and exceeding Customer needs.

how to succeed

The ideal candidate will have:

• Proven experience in a Quality role in the biotechnical or pharmaceutical industry. A minimum of 4-6 years of working experience in a GMP-regulated environment

• Bachelor or higher degree in Biochemistry, Biology, Pharmaceuticals, or other relevant education.

• Excellent understanding and application of Global Regulatory (cGMp/ICH/FDA/EMA) guidelines.

•  Experience in Quality oversight in the establishment of a Laboratory, e.g. Test Method Transfer and Validation, is a necessity

• Independent problem solver in a complex environment, balancing business needs, 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.

benefits

This role offers a very competitive hourly rate, a hybrid way of working & a supportive working environment. This contract will run initially for one year.

you are welcome here

Janssen is an innovative pharmaceutical company: we work every day on the frontline of health innovation. We can only meet this challenge because of our talented employees. Working at Janssen means that you get every opportunity to optimally develop your career.

about Janssen Biologics

Janssen is the Pharmaceutical Company of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare Company. At Janssen, we bring together top scientists and researchers to pursue the most promising science and drive collaboration to create visionary medicines and healthcare solutions covering five priority therapeutic areas - Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, and Oncology. Contribute to the next pharmaceutical breakthrough with your next project at Janssen. 

https://www.janssen.com/netherlands/nl

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. 

questions

If you would like some additional information about the role please contact:  katerina.alikaridou@randstadsourceright.nl

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.