Quality Manager

We are looking for an experienced Compliance & Quality Manager, ideally with a background in pharmaceutical manufacturing or another highly regulated medical production environment.
 

This role is for someone who is detail-oriented, understands the critical importance of procedures, documentation, inspections, and is ready to dive deep into physical operations—including our clinics, labs, and donor-related processes. Your goal will be to bring pharma-level discipline and regulatory excellence into our reproductive medicine practice.
 

Your Key Responsibilities:

Regulatory Compliance & Audit Readiness

  • Ensure ongoing compliance with local and international healthcare regulations (FDA, EMA, GMP, ESHRE, etc.).
  • Maintain audit readiness at all times.
  • Create, update, and implement SOPs and quality documentation across multiple locations.
  • Read and interpret regulations, apply them to internal processes, and prepare for licensing procedures.
  • Physically review documentation and folders related to donors and clinical cases on-site.

Quality Management

  • Identify and assess risks across labs, clinics, and IVF-related procedures.
  • Investigate quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPAs).
  • Use structured tools like risk matrices, Ishikawa/fishbone diagrams, etc.

Risk & Issue Management

  • Identify and manage risks in lab and IVF procedures.
  • Investigate quality issues, find root causes, and implement corrective actions.
  • Use tools like risk matrix and fishbone diagrams for issue analysis.

Training & Team Support

  • Train cross-functional teams on SOPs, quality standards, and regulatory updates.
  • Promote a strong culture of quality, safety, and accountability.

Communication & Reporting

  • Collaborate with management, clinical, and laboratory teams.
  • Act as the main point of contact during inspections and audits.
  • Prepare clear reports on compliance status, risks, and audit outcomes.
     

What We’re Looking For

  • 3+ years of experience in compliance or quality assurance in pharmaceutical or medical production.
  • Hands-on understanding of regulated environments (GMP, GLP, ISO 13485, or similar).
  • Experience working directly with documentation, physical locations, and licensing bodies.
  • IVF or reproductive medicine background is a strong plus but not required.
  • Confident reading and interpreting regulations and official guidelines.
  • Strong English communication skills (B2–C1).
  • Excellent organizational, analytical, and problem-solving skills.

 

What We Offer

  • Competitive Salary that reflects your experience and value.
  • International Team with a stable, supportive work environment.
  • Comprehensive Benefits to support your well-being and growth.
  • Professional Team that loves what they do and is always improving.
  • Freedom to Innovate – we welcome your ideas for improvements.
     

Apply today to join our team!

Published 4 April
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