QA Specialist

Vacature

CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Johnson & Johnson Innovative Medicine we are searching for a QA Specialist.

Keywords

• Quality Assurance
• GMP Compliance
• Batch Release
• Deviations
• Change Control

As a QA Specialist, you play a key role in supporting commercial and clinical production at the Sassenheim site. You serve as the primary quality contact for all Advanced Therapies (AT) activities on site, ensuring compliance with GMP standards across production and quality control labs. In this role, you provide independent quality oversight, pragmatic advice, and collaborate closely with cross-functional teams such as Operations, QC, MSAT, and Warehouse.
You are responsible for GMP compliance related to change control, document management, training, validation, aseptic processing, and tech transfers. You lead and support quality investigations, assess non-conformances, and oversee CAPAs. As Quality SME, you contribute to inspection readiness, risk assessments, training, and continuous improvement initiatives. You also support global escalation processes, approve documentation and change controls, and act as QA representative during audits (e.g., FDA, EMA). In this role, you proactively identify compliance risks, lead quality-related projects, and ensure all activities meet global regulatory requirements.

Profiel

The ideal candidate holds a Bachelor's or Master's degree in Biochemistry, Biology, Pharmaceutical Sciences, or a related field, combined with at least 3+ years of experience in a GMP-regulated environment. You have a solid understanding of the biotechnological or pharmaceutical industry and are well-versed in global regulatory guidelines such as cGMP, ICH, FDA, and EMA. With hands-on knowledge of quality systems (change control, deviation management, validation), manufacturing processes, and technical automation, you can operate independently and make sound, risk-based decisions.
You bring strong analytical and problem-solving skills, ideally supported by methods like Process Excellence, Co-Think, or Kepner-Tregoe. You’re a collaborative professional who communicates clearly, influences without formal authority, and thrives in dynamic, cross-functional environments. With a pragmatic mindset and a customer-oriented approach, you balance compliance, efficiency, and business needs effectively.

Arbeidsvoorwaarden

Project for at least one year. Extension possible.
Salary: 45000 - 70000
Days of leave: 36
See here our other employment terms for this vacancy

Bedrijfsprofiel

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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.

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Contact

Interested? Send us a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form. (See URL) (Vacancy number A2500041)