Job Specifications
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 ts 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.
About the Company
LIVE BACTERIAL PRODUCTS DONE RIGHT Live Bacterial Products (LBPs), where the active indredient is a living bacterium, are part of a fast growing new class of products which most CDMOs approach empirically. As CDMO solely focussed on LBPs, BioLyo Technologies approaches LBP development (medium, fermentation, formulation, lyophilization, drug product formulation) in an integrated manner, respecting the interdependency of the process steps involved.
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