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Quality Assurance Director

Jobleads-US
Allendale, MI Full Time
POSTED ON 4/5/2025
AVAILABLE BEFORE 5/2/2025

Job Overview:

nChroma Bio is a pioneering biotechnology company redefining the future of in vivo targeted genetic medicine. We're building a culture and organization to support our mission, bringing together individuals that thrive in a supportive environment where diverse perspectives and a passion for discovery drive cutting-edge science and breakthrough medicines.

About the Role:

  • Responsible for the strategic development and execution of nChroma's quality assurance programs
  • Accountable for overall quality and compliance oversight to include manufacturing, supply chain, nonclinical, and clinical functions
  • Establish and manage Quality and Compliance Training program for GxP employees and contractors
  • Ensure quality metrics comply with best industry standards and practices

Requirements:

  • A minimum of 10 years GMP QA management experience in the Biotech/Pharmaceutical industry
  • Expertise in current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and relevant regulations across multiple jurisdictions
  • Extensive knowledge of GMP guidelines, regulatory requirements, and industry best practices
  • Proven experience in leading quality assurance teams and managing complex quality systems

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