About the Company
An international biopharmaceutical organization is establishing a new Lentiviral Vector (LVV) production facility in Sassenheim. This site will support the manufacturing of advanced therapies used in the treatment of multiple myeloma. The project team is preparing the facility for commercial production and is focused on building a strong GMP-compliant foundation to ensure the highest standards of quality, safety, and regulatory compliance.
Role Description
As a GMP Compliance Specialist, you support the BU5 organization with in-depth expertise on GMP processes, systems, and compliance standards. You are part of the Centre of Expertise (CoE) team, which plays a critical role in supporting both Operations and New Product Introduction (NPI). The CoE ensures that developed processes are translated into compliant, workable shop floor solutions in line with cGMP and applicable regulations, including Annex 1.
Key Responsibilities
- Review and improve general LVV GMP documentation to maintain ongoing compliance
- Initiate and manage change controls related to GMP production processes
- Lead deviations and root cause investigations, ensuring timely closure of non-conformance records
- Facilitate and participate in Quality Risk Assessments (QRAs)
- Support and coordinate internal and external audits in roles such as SME, primary contact, scribe, or back-office lead
- Coordinate internal batch release activities
Requirements
- Bachelor’s or Master’s degree in Science, Engineering, or a related field
- 3+ years of experience in a biotechnology or biopharmaceutical GMP production environment
- Strong knowledge of current Good Manufacturing Practices (cGMP); familiarity with Annex 1 is preferred
- Experience working with quality systems (e.g., Comet, TruVault or similar)
- Proficiency in Microsoft Office tools including Excel, Word, Visio, SharePoint, and PowerPoint
- Excellent communication skills in English; Dutch is preferred
- Strong stakeholder management and influencing skills within a complex matrix organization
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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
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