Johnson & Johnson
Quality Control
Location: Leiden
Duration: 12 months contract
Hours: 40h
Hybrid way of working
Imagine your next role in the Quality Department as a Product Lead where you will be the owner of the End to End process of Release and Stability sample testing within the Quality Control department in Leiden.
About the department
The Leiden Quality Control (QC) Leiden department is a Business Unit within the Leiden Janssen Biologics site, a biotherapeutics and vaccines manufacturing site belonging to the Janssen Supply Chain. The Leiden QC department is responsible for raw material, in-process, and release testing for products manufactured at the site. Additionally, the Leiden QC department has a unique global responsibility and exposure by being the stability testing hub for large molecule products within the Janssen Supply Chain, and by partnering with multiple CMOs to perform the release testing. The department is structured in different testing laboratories and supporting teams, which are divided based on specific techniques and/or expertise.
All test laboratories are supported by the Release & Stability team, which is integrated by-product E2E QC owners who lead and coordinate the release and stability testing processes for commercial products through deep expertise and effective communication between global stakeholders (e.g. DPDS, PQM, VPAD, VCM, CMOs, EQ) and Leiden QC.
Realise & Stability is the main point of contact at QC Leiden for QC laboratories, for other departments within Leiden, and for external sites. Contributing to a smooth release process and maintaining the stability of programs. Providing communication and support upon any exception to the regular processes or any ad hoc queries for QC.
The Release & Stability team leads and supports complex non-conformance investigations, initiates improvements to optimize the testing strategy and execution, and owns the Life Cycle Management activities for the commercial products tested at Leiden QC.
Responsibilities
Fully owns end-to-end product testing process within Leiden QC with some support.
Coordinates the release of raw materials drug substances and drug products from internal and external stakeholders (CMOs) to ensure on-time delivery of results per agreed timelines.
Coordinates the stability testing of JSC large molecule products according to local procedures and agreed timelines.
Acting as Subject Matter Expert on release and stability processes and has a leading role during the GMP inspections.
Participates in meetings of the quality network organization and partners with customers (e.g. CMOs, JSC manufacturing sites, PQM) to ensure a flawless experience.
Responsible for coordinating all data requests provided by various stakeholders (e.g. RA; Health Authority; DPDS) and has the accountability to plan, organize, prioritize, and execute the data Requests based on the stakeholder requests.
Responsible for reviewing the CPV plans and matrixes and updating the QC release trend limits accordingly.
Provide input for the YBPR and APR requests.
Leads and drives continuous improvement projects.
Adhere to compliance best practices, EHSS regulations, and lean principles.
Perform other work-related activities assigned by the supervisor.
Maintain compliance with all company policies and procedures
To be successful in this role you have:
Bachelor’s degree (or equivalent) in a relevant discipline with 2-4 years of related working experience.
Excellent verbal and written communication skills, including the ability to effectively communicate with internal and external customers.
Didactical skills to effectively transfer information in a training environment.
Advanced knowledge of lab systems and lab environment, data integrity, and data management.
Proactive stakeholder management
Knowledge of statistical data analyses.
Lean/BE experience
.
benefits
This role offers a very competitive hourly rate & a supportive working environment. This contract will run initially for 12 months.
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
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/janssen-nederland/biologics-leiden
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.
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 in the Netherlands are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every 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”!