Vacancy number: A2500041
Johnson & Johnson Innovative Medicine - Sassenheim (Nederland)
For our client, Johnson & Johnson Innovative Medicine, we are looking for a QA Specialist.
Johnson & Johnson Innovative Medicine - Sassenheim (Nederland)
For our client, Johnson & Johnson Innovative Medicine, we are looking for a QA Specialist.
Keywords
- Quality Assurance
- GMP Compliance
- Batch Release
- Deviations
- Change Control
Profile
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.
Who we're looking for
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.
Company profile
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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Additional vacancy information
| Reference | : | A2500041 |
| Contract | : | Temporary contract with CLS Services |
| Education | : | WO/MSc. HBO/BSc. |
| Employment terms | : | Project for at least one year. Extension possible. Salary: 45000 - 70000 Days of leave: 36 See here our other employment terms for this vacancy |
| Publication date | : | 2-7-2025 |
| Location | : | View location with Google Maps |
| Contactperson | : | Aniek Vugts |
| +31 (0)88 22 77 555 |
CLS Services is a leading professional recruitment agency, specialised in the recruitment and secondment of people with a background in chemistry & life sciences.
