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Amaris is looking for a QA Specialist to support a leading pharmaceutical client in managing quality oversight of Contract Manufacturing Organizations (CMOs) within the External Manufacturing – Drug Product (EM Q DP) team. This role ensures product quality, regulatory compliance, and efficient collaboration across QA, IT, and operational departments in a global matrix environment. You will play a key role in batch release, deviation/CAPA management, change control, and market complaint review, ensuring end-to-end quality accountability for outsourced manufacturing activities.
Job Responsibility:
Ensure end-to-end quality accountability for CMOs, including oversight of: Deviation investigations
CAPA implementation and closure
Change control assessments and approvals
Support product batch release processes in compliance with cGMP and regulatory requirements
Review and approve market complaints, ensuring timely and compliant evaluation
Collaborate with QA, IT, Regulatory, and Supply Chain teams within a complex, international matrix
Contribute to audits, regulatory inspections, and continuous improvement initiatives
Apply a pragmatic, problem-solving approach to quality challenges, balancing risk and operational needs
Requirements:
University degree in a scientific field: Bioengineering, Biology, Biotechnology, Pharmacology, Chemistry, or equivalent
4–6 years of experience in a cGMP-regulated environment (pharma, biotech, or healthcare)
Solid understanding of GMP, regulatory requirements, and quality systems in manufacturing
Good knowledge of SAP and Veeva is mandatory (or similar QMS/document management systems) is a strong asset
Analytical mindset with a global, pragmatic approach to problem solving
Proven ability to influence, network, and collaborate across functions and cultures
Fluency in French and English is mandatory
Nice to have:
Good knowledge of SAP and Veeva is mandatory (or similar QMS/document management systems) is a strong asset
What we offer:
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe