QA Systems Specialist

QA Quality Systems Training & Documentation

Location: Leiden, Archimedesweg

Duration: End of year (December 2026)

Hours: Full time

Work type: Hybrid (3 days on-site, 2 days remote)

Imagine your next project contributing to the manufacturing of clinical material, including MCB, WCB, preMVS, seeds, and DS, as part of a dedicated team at the Janssen Vaccines Leiden site.

Janssen Vaccines Leiden (JVL) site is dedicated to the manufacturing clinical material. i.e. MCB, WCB, preMVS, seeds and DS. JVL primarily manufactures clinical trial batches as pre- formulated bulk DS. In process testing, release testing and stability monitoring is performed on site or outsourced.

The job holder is part of QA Quality Systems team and performs its duties to coordinate and/ or enable proper oversight, support and management of the Quality systems used by Janssen Vaccines Leiden. The job holder is responsible for proper execution of its job according to expectations as defined in GMP, Quality, Regulatory and J&J Compliance guides and regulations.

QA Specialist will independently perform standardized tasks in accordance with official procedures and processes. The focus is on managing and support of the J&J Quality systems for Document Management (Truvault) and Training management (Summit).

roles and responsibilities.

• Documentation Management:

  • Acts as TruVault SME for system training, support and administration.

  • Reviews as SME documents for compliance with GMP regulations; guidance, company standards and other SOPs for impact on patient safety and product quality.

  • Acts as SME for internal and external archiving.

  • Manages issuance and archival of quality records like test records, external reports, logbooks etc. onsite and off-site for long term preservation, and provides content of superseded and obsolete documents upon request.

• Training Management

  • Maintains the Learning Management System (LMS) in support of the operational departments.

  • Acts as first point of contact for training for the PDQ department and Departmental Training Delegates (DTD).

  • Organizes JVL Site based training, including maintenance of a matrix and coordinates the local training related procedures and ensures yearly training record review for department.

  • Supports Department Manager regarding training related responsibilities.

  • General Quality Systems support

  • Can act as Superuser for TruVault, Summit and other relevant J&J Quality systems.

  • Issuance of Initials to be used on company documents.

• Internal auditing and inspections, Regulatory requirements

  • Assists with preparation and provides support for internal audits, regulatory authority inspections and JJRC inspections

how to succeed.

• Must be able to understand, read and write in English. Dutch is a bonus

• GMP / GxP Experience is essential

• Bachelor’s degree in a life science study or equivalent experience

• 1-3 years of experience in a pharmaceutical environment within compliance

• Good organizational capabilities

• Flexible and accurate

details

This role will run until the end of 2026. It is a hybrid position (3 days on-site, 2 days at home) and is full time (40 hours per week)

you are welcome here.

Johnson & Johnson is 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.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

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 or LinkedIn InMail - you must apply direct to this advert.

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”