Job description
Mission
We are looking for a Project Manager with an expertise in CQV in the pharmaceutical sector. You will drive the roll-out of a new global Engineering Standard (ES) across 12 manufacturing buildings in Belgium. Your work ensures that facility design requirements meet both health-authority regulations and the company’s internal standards.
Key Responsibilities
1. Gap Analysis
• Compare the new ES against existing Belgium SOPs and identify discrepancies.
2. Risk Assessment Leadership
• Plan, facilitate and document risk assessments with local subject-matter experts for each manufacturing unit.
• Standardise evidence collection and mitigation strategies across sites.
• Track milestones and report progress to the ES duty holder and sponsor.
3. Remediation Support
• Help manufacturing units draft remediation plans for any gaps uncovered.
4. Project & Stakeholder Management
• Coordinate cross-functional teams in a matrix, multicultural environment.
• Balance multiple priorities under tight timelines while maintaining quality.
Must-Have Profile
• 4–6 years’ experience in product & process engineering within pharma/biotech.
• Proven project-management track record (planning, budgeting, risk, timeline).
• Hands-on expertise in risk-assessment methodologies (e.g., FMEA, HACCP).
• Demonstrated success in stakeholder management and negotiation at all levels.
• Analytical mindset with strong information-organisation skills.
• Self-starter who thrives in high-pressure, team-oriented settings.
• Fluent in French and English (written & spoken).
Nice to Have
• Experience with GMP facility design or validation projects.
• Familiarity with regulatory inspections (EMA, FDA).
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