Are you a seasoned QA professional passionate about driving quality in biologics manufacturing? Do you thrive at the intersection of strategic oversight and hands-on execution? A dynamic biotech company based in Ghent is seeking a Senior QA Lead – Outsourced Manufacturing to play a pivotal role in ensuring product quality, supporting FDA inspections, and overseeing external manufacturing partners as they prepare for commercial launch.
This is a unique opportunity to shape quality strategies, oversee CDMO partnerships, and ensure regulatory compliance, directly impacting the development of next-generation live bacterial vaccines and therapeutics.
Your daily work
* Provide QA oversight of CDMO partners producing Drug Substance, Drug Product, and Cell Banks, ensuring compliance with cGMP, quality agreements, and regulatory requirements.
* Audit and qualify CDMO facilities and QMS for cGMP readiness, PPQ, and FDA/EMA inspections, and lead PAI readiness strategies.
* Act as Person-in-Plant (PIP) during key manufacturing activities, ensuring quality execution on the ground.
* Review and approve key documentation (tech transfer, master batch records, deviations, CAPA, change controls, OOX) and assess batch records, investigations, and risk assessments.
* Support QC testing, batch release, and stability programs, and drive continuous improvement of the QMS and eQMS systems.
* Collaborate cross-functionally with QA/QP, QC, CMC, and Development teams, contributing to audits, risk assessments, and management reviews.
What you bring
* MSc or higher in Pharmaceutical Sciences, Bioengineering, Biomedical Sciences or similar.
* 10–15 years of QA experience in GMP biotech/pharma, ideally in late-stage clinical and commercial biologics.
* 5+ years managing outsourced manufacturing (CDMOs), including tech transfer, PPQ, and BLA support.
* In-depth knowledge of cGMP (EudraLex Vol. 4), 21 CFR, EP/USP, ICH, WHO guidelines and experience preparing for PAI and FDA inspections.
* Proven expertise in QMS development, audits, data integrity, and regulatory compliance.
* Strong communication, leadership, and collaboration skills; English fluency required, other languages a plus.
What makes you stand out
* Demonstrated success with process validation, PPQ, and Phase III to commercial transition.
* Experience implementing and validating eQMS and computerized systems.
* A hands-on, pragmatic, and solutions-focused mindset combined with strategic leadership.
Why this is interesting for you
In this high-impact role, you’ll be the key quality voice driving innovative live biotherapeutic products to market. Working closely with CDMOs and regulatory authorities, your expertise will ensure products meet the highest standards of quality and compliance — shaping the future of biotherapeutics in a fast-growing, innovative environment.
Interested?
Apply below or reach out directly: k.vongeusau@panda-int.com