You will combine hands-on Quality Assurance with audit and inspection activities and broader Quality Management System (QMS) responsibilities. You will play a key part in ensuring quality and compliance across an organization's operations. Around 50% of your time will be dedicated to compiling and reviewing batch documentation, 30% on broader QMS activities, and 20% to supporting audits and self-inspections.
You will work closely with Qualified Persons (QPs) and Quality colleagues to ensure documentation is complete and correct, Quality actions are followed up, and operations remain compliant. You will also help to improve Quality processes and ways of working as the site develops.
What you will do.
- Review batch documentation for batch disposition/QP certification.
- Identify missing or incomplete documentation, coordinate actions with the right teams, and follow them through to completion.
- Write, review, and update SOPs, procedures, policies, and Quality documents.
- Review Quality and manufacturing records and identify gaps, risks, deviations, and required follow-up.
- Investigate Quality deviations and coordinate corrective and preventive actions (CAPAs).
- Review and approve Change Controls.
- Review Quality documentation for equipment and facilities as a Cell Therapy Import Hub is built.
- Use available digital and AI tools to improve and update Quality documentation.
- Host audits for Health authority inspections on site, including preparation, front room and backroom support, and follow-up.
- Coordinate audit and inspection activities.
- Compile, coordinate, and draft responses to audit and inspection findings, working with the business to ensure responses are complete and consistent.
- Own the CAPAs arising from audits and inspections, coordinate them with the responsible teams, and follow them through to completion.
- Conduct self-inspections on site and drive the actions that come out of this to closure.
Profile
- Experienced in audits and inspections, you know what auditors and inspectors look for and stay calm and organised when they are on site.
- Enjoy detailed documentation-driven work, like reviewing documents, checking details, and making sure Quality records and Batch documentation are complete, correct, and compliant.
- Take ownership. When something needs attention, you follow it up, involve the right people, and make sure it gets resolved, including the CAPAs that follow an audit.
- Will work in a small Quality team on a site that is still developing. Processes and priorities can change as the organization builds. You are comfortable with this, stay calm under pressure, and look for practical solutions.
- Self-motivated, flexible, and curious. You can manage several priorities at the same time and actively look for ways to improve how things are done.
What they ask
- A bachelor’s or master’s degree.
- Experience hosting audits and Health authority inspections.
- Experience coordinating audits and inspections, compiling responses to findings, and managing the resulting CAPAs.
- Experience conducting self-inspection.
- At least 2 years of hands-on Quality Assurance experience in a GMP manufacturing environment.
- At least 2 years of experience writing and reviewing Quality documentation, including SOPs and procedures.
- At least 2 years of experience with deviations, CAPAs, and change controls.
- Experience reviewing batch documentation and Quality records.
- Good knowledge of GMP and Quality Systems and of broader QMS management.
- Knowledge of and ability to apply GMP in conformance to US, EU, and ROW standards.
- The ability to identify gaps and risks in Quality records and determine what follow-up is needed.
- Experience working with an electronic QMS.
- Professional proficiency in English; Dutch is a plus.
Preferences.
- Experience in Cell Therapy is a strong advantage, especially because of the specific requirements around batch disposition and release.
- Experience in biologics is also highly relevant.
How to apply
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