Senior QA Specialist

About BioLyo
BioLyo Technologies is a dynamic biotech company based in Ghent, Belgium, dedicated to the development of live
bacterial micro-organisms to be used as live vaccines or live biotherapeutical products (LBPs). The company provides
services to third parties to help speed up the development of their Live Biologicalsby offering GMP compatible and
scalable process development, analytical development, process characterization and GMP QC services. Areas of
expertise include medium optimization, fermentation & harvest strategies, and pre-and post-lyophilization
formulation of live biological products. Quality by Design principles and Design of Experiments software are applied to
perform process characterization to work towards commercial manufacturing, a service few CDMO’s offer. As a
growing company, BioLyo has implemented a QMS, has a cGMP license for Quality Control testing of Investigational
Medicinal Products (IMPs), and offers QC testing services for batch release and stability studies. In addition, BioLyo
manages the cGMP manufacture of IMPs at contracted CDMOs to support pre-clinical and clinical phases I to III for its
clients.

Due to expanding activities, BioLyo needs to strengthen its team with a Senior QA Specialist. This role will be a key
subject matter expert in Quality, contributing to Quality strategies.

Job Description:
- Work in close collaboration with the QA Manager/QP, QC Manager, CMC outsourced manufacture and
Process and Product Development Manager at BioLyo.
- Support the QA Manager/QP to continuously improve the QMS of BioLyo.
- Demonstrate leadership relative to sharing of QA knowledge and experience across the organization. 
- Define and execute PAI readiness strategies for the BioLyo QC laboratory and contracted CDMO, and work
towards a commercial manufacturing license.
- Give input to management review meetings.
- Support the execution of the internal audit program.
- Drive implementation and validation of an eQMS
- Ensure data integrity and computerized system validation.
- Give input to risk assessments (process and quality related)
- Audit CDMO facilities and their respective Quality Management Systems (QMS) to ensure readiness for cGMP
production, process performance qualification, and health authority inspections.
- Establish and maintain CDMOs as qualified vendors for Drug Substance, Drug Product and Cell Bank
production.
- Quality oversight of manufacturing activities and the QMS of the CDMO. Ensure that the activities of the
CDMO are performed in compliance with cGMP, relevant procedures, Product Specification Files and Quality
Agreements.

- Oversee PAI readiness at the contracted CDMO where IMP manufacture takes place.
- Work in close collaboration with the QA lead outsourced manufacture
- Review and approval of Tech Transfer documentation, Master Batch Records, specifications, etc.
- Quality reviewer/approver for QMS records including deviations, change controls, CAPA and internal and
external OOX.
- Review of executed batch records, root cause investigations and risk assessments.
- Timely identification and communication of risks and gaps that could affect cGMP compliance at CDMO and
at BioLyo; implementation of risk mitigation measures to close any gaps.
Education and Competences:
- A minimum of a Master’s Degree in pharmaceutical science, bioengineering, biomedical sciences or a related
field, or equivalent experience.
- Minimum 10 to 15 years of QA experience in a GMP environment in pharma or biotech, in late stage clinical
and commercial manufacture.
 - Minimum of 5 years of experience in QA in overseeing outsourced manufacturing activities, preferentially for
biologicals.
- Demonstrated experience with cGMP (EudraLex Vol 4)/ working knowledge of EP/USP, ICH/WHO guidelines,
and 21 CFR and guidance documents
- Demonstrated experience with Process Performance Qualification (PPQ) and successful filing of a Biologics
License Applications (BLA) from a QA perspective.
- Participated in on-site Health Authority inspection, including US FDA inspections.
- Ability to work on site, located in the vibrant Tech Lane Ghent Science Park in Zwijnaarde
- Good written and verbal communication, planning and organization skills.
- Fluent in English written and spoken. Knowledge of Dutch, Spanish or Portuguese is a plus.
- Ability to work in a motivated team in a dynamic and fast-paced environment.
- Ability to work independently and guide QA team memberss
- Accurate, precise, detail-oriented, critical, pragmatic and problem solving.

Please send your application, including your CV and a motivation letter to info@biolyotech.com before 30 October
2025.