Company context
A rapidly growing biotech company based in Ghent is focused on developing live micro-organisms for use as vaccines and biotherapeutics. To strengthen its expanding outsourced manufacturing network, the company is looking for a Senior QA Consultant to provide subject-matter expertise and quality oversight of CDMOs. This assignment plays a key role in ensuring cGMP compliance and inspection readiness throughout late-stage clinical development.
Scope of work
The consultant will:
* Conduct audits of CDMO facilities and quality systems to ensure readiness for cGMP manufacturing, PPQ, and regulatory inspections.
* Qualify and manage CDMOs for drug substance, drug product, and cell bank production.
* Provide quality oversight of external manufacturing activities, ensuring compliance with cGMP, Product Specification Files, internal procedures, and Quality Agreements.
* Lead and implement Pre-Approval Inspection (PAI) readiness strategies with CDMOs and internal stakeholders.
* Serve as Person-in-Plant during manufacturing campaigns and critical operations.
* Review and approve key documentation (Tech Transfer, Master Batch Records, specifications, deviations, change controls, CAPAs, OOX).
* Assess executed batch records, root cause analyses, and risk assessments.
* Identify, communicate, and mitigate risks impacting GMP compliance.
* Collaborate closely with CMC, QA, QC, and Development leadership.
* Support continuous improvement of the internal QMS and contribute to eQMS implementation and validation.
* Ensure data integrity and computerized system validation requirements are met.
* Contribute to the internal audit program and quality risk assessments.
Profile required
* Master’s degree in pharmaceutical sciences, bioengineering, biomedical sciences, or equivalent.
* 10–15 years of QA experience in GMP pharma/biotech, ideally in late-stage clinical development.
* Minimum of 5 years overseeing outsourced manufacturing, preferably with biologicals.
* In-depth knowledge of cGMP (EudraLex Vol 4), EP/USP, ICH/WHO guidelines, and 21 CFR.
* Proven experience with PPQ and BLA submissions from a QA perspective.
* Hands-on experience with Health Authority inspections (including US FDA).
* Strong communication, organizational, and planning skills.
* Fluent in English and Dutch.
* Ability to thrive in a fast-paced, dynamic environment while providing leadership and knowledge transfer.
Why this can be interesting for you?
A chance to bring your QA expertise into an environment where late-stage development, method transfer, and validation genuinely make the difference. You’ll be contributing to complex, impactful products while having the freedom to apply your knowledge and continue developing your skills.
Are you interested?
Please contact me directly at t.sylla@panda-int.com