Job description
About the Role
To support a growing portfolio of pharmaceutical projects and upcoming product launches, we are reinforcing our Pharma MSAT Quality team with an experienced MSAT Quality Lead.
You will play a key role in complex technology transfer projects, ensuring supply continuity and providing second-line quality support across both internal and external manufacturing sites. This is a project-driven role with strong potential for extension, depending on project milestones and budget.
You will join a relatively new, dynamic department (created ~1.5 years ago), currently composed of 4 internal MSAT Quality Leads and an extended outsourced team (total ~12 people). The team operates in a highly cross-functional, international environment where English is the main working language.
You will collaborate closely with:
* Internal & External Manufacturing
* CMC Development Sciences
* Industrialization & Network Planning
* Global Quality and other business stakeholders
Key Responsibilities
On a typical day, you will be involved in a mix of project and transversal quality activities, including:
Technology Transfer & Validation
* Support technology transfers (process and/or analytical) for Drug Substance (DS), Drug Product (DP), and Packaging.
* Ensure quality oversight during process validation and continuous process verification (CPV).
Quality Troubleshooting & Expertise
* Act as second-line support for complex or cross-site quality issues.
* Provide QA expertise during complex investigations and in the definition and follow-up of CAPAs.
* Challenge and review technical content from an operational QA perspective.
Project & Stakeholder Management
* Participate in cross-functional meetings, ensuring alignment on timelines, risks, and deliverables.
* Maintain close follow-up on project milestones and proactively escalate issues when needed.
Transversal / Peak-Load Support
During ramp-up or peak periods, you may also:
* Contribute to quality agreement preparation and review.
* Support vendor-related QA activities.
* Temporarily support other quality teams facing high workload.
Profile & Experience
* Experience:
o Minimum ~5 years of relevant experience in a similar role.
o Strong background in pharmaceutical quality and operations is strongly preferred.
* Seniority:
o Able to operate autonomously, take part in complex technical and quality discussions, and act with limited supervision.
Must-Have Skills & Competencies
* Strong Quality mindset with a solid understanding of pharmaceutical regulations (GMP and related guidelines).
* Proven experience in technology transfer (process and/or analytical), ideally in a QA context.
* Operational QA experience with the ability to understand, challenge, and defend technical content.
* Hands-on experience with complex investigations, deviation management, and CAPA lifecycle.
* Excellent communication skills in English (written and verbal).
* Ability to work independently in a cross-functional, international, and multicultural environment.
Nice-to-Have
* Experience in both process and analytical domains.
* Exposure to different formulations and stages: DS, DP, and packaging.
* French language skills.
* Experience in biologics and/or non-pharma industries, provided the quality and tech transfer mindset is strong.
* Previous experience working in global or multicultural teams.
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.