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Amaris Consulting Logo Amaris Consulting · IT - Administration

Program Manager Pharmaceuticals

Belgium, Wavre · Job Posted June 14, 2026
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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.

Job Responsibility

  • CMO Quality Oversight & Governance: Take accountability for main quality activities related to CMO management
  • Review and follow up on deviations, ensuring appropriate investigation and documentation
  • Monitor and support CAPA implementation and timely closure
  • Manage and assess change controls linked to CMOs and their impact on product quality
  • Help put in place and maintain governance for quality processes and interactions with CMOs
  • Batch Release & Complaints: Provide support for product batch release activities (documentation review, quality decision support)
  • Ensure the review and approval of product market complaints related to externally manufactured products
  • Contribute to root cause analysis and definition of corrective and preventive actions
  • Lean Management & Continuous Improvement: Drive or support continuous improvement initiatives within EM Q DP and across QA/IT matrix teams
  • Apply lean management principles to streamline quality processes and improve efficiency
  • Manage and coordinate the impacts of process changes on quality systems and CMO activities
  • Align with stakeholders on planning, priorities, and deliverables

Requirements

  • University degree with a scientific orientation (Bioengineering, Biology, Biotechnology, Pharmacology, Chemistry) or equivalent experience
  • 5 years of experience in a GMP/cGMP environment (pharma, biotech, or similar regulated industry)
  • Strong knowledge of GMP and regulatory requirements
  • Experience in quality assurance activities: deviations, CAPA, change control, complaints management
  • Experience in lean management, continuous improvement, and governance of processes
  • Not a hands-on technical lab/production role – focus on process, governance, and QA oversight
  • Knowledge of SAP and VEEVA is a strong asset
  • Analytical and critical mindset, with a global and pragmatic approach
  • Strong problem-solving skills
  • Good impact and influence capabilities and networking skills to work efficiently within QA, IT, and other operational departments in a matrix organization
  • Good technical writing skills (procedures, reports, rationales, quality documentation)
  • English: mandatory (oral and written)
  • French is a plus

Nice to have

  • Knowledge of SAP and VEEVA is a strong asset
  • French is a plus

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
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