Senior QA Specialist

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

About Clinical Supply Quality Operations

The Operations team is part of the Clinical Supply Quality (CSQ) department at the Advanced Therapies (AT) Leiden site, which has recently transitioned into a pilot plant for the manufacturing of cell and gene therapy Investigational Medicinal Products.

CSQ is responsible for the end-to-end Quality & Compliance oversight for the internal and external clinical supply leading up to the release and certification of Investigational Medicinal Products used in clinical trials.

The group is forward-looking, working on improving processes, being customer oriented and supporting innovation and agility.

We are searching for the best talent for the position of Senior QA Specialist.

Purpose :

The Senior QA Specialist will join a multidisciplinary and dynamic team responsible for the aseptic manufacturing (fill line) processes of early-stage clinical materials. They will focus on QA oversight of activities during manufacturing such as aseptic filling, visual inspection and APS. They will manage documentation and internal checks, procedures and training for manufacturing activities as well as investigation into non-conformances.

Additionally, the Senior QA Specialist has opportunities to collaborate with other members of CSQ in support of release of raw materials, batch record reviews, improvement projects and change controls.

Personal development is an important aspect for any new team member. We offer an exciting position in a dynamic and international environment, ensuring diversity in your work and creating opportunities for personal development.

You will be responsible for:

• Review of documentation and procedures related to manufacturing activities such as fill and finish, visual inspection, aseptic process simulation, operator qualification

• Oversight of the manufacturing processes, including direct witnessing of the execution of the various tasks by the plant operators

• Acting as QA lead during investigations and Change Controls, as well as supporting CAPA executions

• Building relationship with applicable partners of the pilot plant and Quality colleagues and Subject Matter Experts in Schaffhausen, Beerse and other J&J sites

• Supporting CSQ Operations team in various site activities and overall compliance with global and local procedures

• Collaborating with functional project teams in a diverse environment to drive team accountability for quality goals

• Applying quality, scientific and engineering principles for problem solving and for providing input to the teams

• Involvement in implementation of new insights, process improvements and departmental strategic discussion

• Complying to EHS and GMP-standards and acts according to J&J Credo principles

Qualifications / Requirements:

• MSc degree in a relevant field, like Pharmacy or Bio-Pharmaceutical Sciences or equivalent

• Proven experience in a pharmaceutical setting, preferably in Aseptic Manufacturing and Quality Assurance / Quality Control

• Technically skilled – experience in pharmaceutical technologies and GMP aspects; ability to learn and implement efficiency in own work

• Independent and precise, with attention to details

• Excellent organization and interpersonal skills; ability to work with various partners and influence decision process

• Proactive in the identification of issues, demonstrates problem-solving capabilities, and timely implements solutions

• Is willing to think and challenge beyond own expertise area

• Language proficiency: English

The candidate fit for the job has affinity with quality and compliance, is independent, accurate, flexible, motivated to work in a team.

Knowledge of aseptic manufacturing processes is needed.

Additional information:

The Senior QA Specialist will report to the Manager CSQ.

Closing date: Monday, 3rd of November 2025.

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