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GMP QA Site lead

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Amaris Consulting

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Location:
Belgium , Mechelen

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Category:
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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Lead the quality assurance for clinical trial materials and companion diagnostics (CDx) in a fast-growing GMP environment. Drive compliance across EU regulations while building and mentoring a high-performing QA team.

Job Responsibility:

  • Implement and maintain QMS compliant with EU GMP, FDA, and ICH guidelines
  • Serve as regulatory authority for batch release decisions (IMP, CDx products)
  • Lead QP oversight for UK clinical trial material releases
  • Drive continuous improvement through risk-based quality systems
  • Supervise 5-8 QA specialists across pharmaceutical and CDx verticals
  • Own recruitment, training, and performance development for your team
  • Set departmental KPIs aligned with global quality objectives
  • Approve CAPA, change controls, and validation protocols for: Pharmaceutical manufacturing processes, CDx IVD device development and manufacturing, Equipment/utility qualification (IQ/OQ/PQ)
  • Lead design verification/validation for CDx products
  • Manage vendor qualification and audit programs
  • Host regulatory inspections (EMA, FDA, client audits)
  • Lead internal audit program (schedule, execute, follow-up)
  • Ensure post-market surveillance compliance for CDx devices

Requirements:

  • Bachelor's in Life Sciences, Pharmacy, or Engineering
  • 7+ years GMP QA experience in pharma/medical device manufacturing
  • Proven team leadership experience (minimum 3 direct reports)
  • Expertise in CAPA, change control, and deviation management
  • Fluent in English and Dutch is mandatory (business proficiency required)

Nice to have:

  • Master's/PhD in relevant field
  • QP eligibility or certification
  • Lead Auditor certification (ISO 13485, GMP)
  • Black Belt/Six Sigma certification
  • Experience with lab establishment in GMP environment
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

Additional Information:

Job Posted:
April 05, 2026

Employment Type:
Fulltime
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