Job description
Context & Mission
This position has been created to revamp and transform the current GMP/GDP Management Review process. Today, Management Review is mainly compliance‑driven and retrospective. The ambition is to evolve it into a forward‑looking, proactive and insight‑driven governance mechanism, connecting quality system performance with:
* Patient safety
* Portfolio and supply risk
* Enterprise decision‑making
The initial focus will be on GMP/GDP, with the ambition to expand the approach across the entire company (Clinical, R&D, Development, Pharmacovigilance, etc.) as part of a broader Quality Transformation program.
Team & Reporting
* Reports to the Corporate Process Owner for GMP/GDP Management Review.
* Joins a small core team (currently 2 people, 3 with this role) within a broader Quality organization.
* Works closely with multiple stakeholders across sites and functions (Quality, Operations, Supply Chain, R&D, etc.).
Key Responsibilities
A typical day combines strategic and operational activities, including:
* Review current GMP/GDP Management Review practices and identify gaps, inefficiencies, and improvement opportunities.
* Engage with internal stakeholders and subject matter experts to gather feedback and requirements.
* Perform benchmarking and best‑practice analysis with other pharmaceutical companies and industry standards.
* Translate complex QMS and performance data into clear insights, trends, red flags, and actionable recommendations.
* Design and propose future‑state Management Review frameworks, governance models, and processes.
* Support implementation at site and operational level, ensuring feasibility and adoption.
* Contribute to workshops, governance forums, and quality transformation workstreams.
* Move seamlessly between strategy and execution, from conceptual design to hands‑on deployment.
Profile & Qualifications
Experience
* 7–10 years of relevant experience in Pharmaceutical Quality, Quality Systems, or related roles.
* Minimum 5–8 years working with Pharmaceutical Quality Management Systems (QMS).
* Senior, autonomous profile – able to operate with minimal supervision (no training capacity available).
* More senior profiles can be considered, provided they fit within the defined rate range.
Must Have
* Strong experience with Pharmaceutical Quality Management Systems (QMS).
* Solid knowledge of GMP / GDP and Management Review processes.
* Proven ability to bridge strategy and operations (from conceptual design to practical implementation).
* Ability to work independently and autonomously in a complex, matrix environment.
* Strong stakeholder communication, facilitation, and influencing skills.
* Analytical mindset with the ability to interpret trends, KPIs, and performance data and derive insights.
* Fluent English (mandatory).
Nice to Have
* French professional is a big plus
* Experience with benchmarking and quality governance frameworks (e.g., ICH Q10, enterprise governance models).
* Familiarity with data visualization environments (e.g., Qlik, Power BI) at a conceptual level (understanding dashboards and data stories; not necessarily building them).
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.