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Director, Research Quality Assurance

Posted 10 days agoViewed

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💎 Seniority level: Director, 10+ years or 7+ years with advanced degree

📍 Location: United States, Canada

🔍 Industry: Biopharmaceutical

🏢 Company: Disc Medicine👥 51-100💰 $225,500,000 Post-IPO Equity about 1 month agoPharmaceuticalBiotechnologyTherapeuticsMedicalHealth Care

🗣️ Languages: English

⏳ Experience: 10+ years or 7+ years with advanced degree

🪄 Skills: GCPComplianceTrainingQuality AssuranceRisk Management

Requirements:
  • BS or equivalent in a scientific discipline with 10+ years of experience
  • Advanced degree with 7+ years of experience in the pharmaceutical industry
  • Extensive knowledge of FDA, EU, ICH regulations
  • Exceptional organizational and communication skills
Responsibilities:
  • Develop and implement quality standards and procedures for GCP/GVP/GLP
  • Lead and conduct internal and external audits
  • Manage audit responses and track CAPAs
  • Provide training on current regulations and compliance issues
  • Represent Quality in project teams
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