Job description
Job Purpose
Within the External Manufacturing you will support Contract Manufacturing Operations (CMO) by overseeing key quality activities. Your role focuses on GMP compliance, governance, and continuous improvement, rather than hands-on technical/operational activities.
You will ensure that products manufactured by CMOs comply with cGMP, regulatory requirements, and internal quality standards, while driving lean management and process optimization.
Main Responsibilities
* CMO Quality Oversight & Governance
o Take accountability for main quality activities related to CMO management
o Review and follow up on deviations, ensuring appropriate investigation and documentation
o Monitor and support CAPA implementation and timely closure
o Manage and assess change controls linked to CMOs and their impact on product quality
o Help put in place and maintain governance for quality processes and interactions with CMOs
* Batch Release & Complaints
o Provide support for product batch release activities (documentation review, quality decision support)
o Ensure the review and approval of product market complaints related to externally manufactured products
o Contribute to root cause analysis and definition of corrective and preventive actions
* Lean Management & Continuous Improvement
o Drive or support continuous improvement initiatives within EM Q DP and across QA/IT matrix teams
o Apply lean management principles to streamline quality processes and improve efficiency
o Manage and coordinate the impacts of process changes on quality systems and CMO activities
o Align with stakeholders on planning, priorities, and deliverables
Profile Requirements
* Education
o University degree with a scientific orientation (Bioengineering, Biology, Biotechnology, Pharmacology, Chemistry) or equivalent experience
* Experience & Knowledge
o 5 years of experience in a GMP/cGMP environment (pharma, biotech, or similar regulated industry)
o Strong knowledge of GMP and regulatory requirements
o Experience in quality assurance activities: deviations, CAPA, change control, complaints management
o Experience in lean management, continuous improvement, and governance of processes
o Not a hands-on technical lab/production role – focus on process, governance, and QA oversight
o Knowledge of SAP and VEEVA is a strong asset
* Skills & Competencies
o Analytical and critical mindset, with a global and pragmatic approach
o Strong problem-solving skills
o Good impact and influence capabilities and networking skills to work efficiently within QA, IT, and other operational departments in a matrix organization
o Good technical writing skills (procedures, reports, rationales, quality documentation)
* Languages
o English: mandatory (oral and written)
o French is a plus
Why joining us?
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.