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!