Quality Control Manager

Kongens Lyngby, Capital Region
Posted 4 days ago
Engineering

About the role

Job summary

The Quality Control Manager will be instrumental in establishing and enhancing the quality control function within a growing organization focused on cell therapies. This role involves collaboration with various teams to develop scalable laboratory workflows and quality systems that comply with GMP standards.

Qualifications

  • MSc or PhD in a scientific field.
  • Minimum of five years of experience in Quality Control within a GMP-regulated environment.
  • Experience in cell or gene therapy is preferred.

Responsibilities

  • Shape and improve the QC function, establishing workflows, capacity planning, and quality systems.
  • Develop and implement QC documentation, including SOPs and protocols, while ensuring equipment qualification and inspection readiness.
  • Lead QC activities for development programs, including analytical method transfer and stability testing.
  • Manage external testing laboratories and drive operational excellence in environmental monitoring and investigations.
  • Foster collaboration and knowledge sharing within the QC organization as it grows.

Skills

  • Strong project leadership and relationship-building abilities.
  • Experience with analytical method transfer, quality systems, and laboratory documentation.
  • Proactive mindset with a focus on building new capabilities.

Education

  • MSc or PhD in a relevant scientific discipline.

Tools

  • Familiarity with laboratory digital systems such as LIMS.
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