For Lonza in Geleen, we are currently looking for an experienced Qualified Person (QP) to join the Quality team at their Cell & Gene Technologies site.
Lonza is a global pharmaceutical manufacturing partner supporting the development and production of advanced therapies for pharmaceutical and biotech companies worldwide. The site in Geleen focuses on Cell & Gene Therapy, one of the fastest-growing and most innovative areas in the life sciences industry.
As a Qualified Person, you will play a crucial role in ensuring that medicinal products manufactured under GMP conditions meet all regulatory requirements before being released for clinical or commercial use.
This is a senior-level position with significant responsibility and direct impact on product quality, regulatory compliance, and patient safety.
Job DescriptionIn this role, you will be responsible for the certification and release of GMP-manufactured batches at the Lonza Geleen site. You will review batch documentation, assess deviations and investigations, and ensure that all products meet the required regulatory standards before release.
You will work closely with teams in Quality Assurance, Manufacturing, Validation, and Regulatory Affairs, ensuring that processes and documentation comply with EU GMP regulations and internal quality standards. Due to the nature of batch certification and the close interaction with manufacturing operations, this position requires on-site presence in Geleen.
Responsibilities- Perform batch certification and release in accordance with EU GMP guidelines
- Ensure that all batches have been manufactured and tested in compliance with regulatory requirements and product specifications
- Review and approve batch documentation, deviations, and OOS investigations
- Support and participate in internal and external audits
- Review and approve validation and qualification activities
- Ensure continuous compliance with EU GMP regulations and regulatory guidelines
- Support quality investigations and risk assessments
- Participate in or manage product recall activities when required
- Collaborate with cross-functional teams to maintain a strong quality culture
We are looking for a senior professional with strong GMP expertise and the authority required for a Qualified Person role.
Requirements:
- Registered Qualified Person (QP) according to EU GMP regulations
- Extensive experience in GMP-regulated pharmaceutical manufacturing
- Proven experience with batch certification and release
- Strong knowledge of deviations, OOS investigations, and GMP compliance processes
- Experience with regulatory inspections and audits is highly desirable
- Strong communication and decision-making skills
- Fluent in English
- Salary between €7,000 and €10,000 gross per month, depending on experience
- This role is also open to freelance contractors (ZZP).
- Full-time position (40 hours per week)
- Location: Geleen
- Contract: temporary until 15 September 2026
- Vacancy number: 27122
This position requires on-site work in Geleen. Candidates should therefore live within commuting distance of Geleen or be willing to relocate. Applications from candidates who do not live near Geleen and do not hold a valid EU work permit or Dutch work authorization will not be considered.
#J-18808-Ljbffr€7000 - €10000 monthly