Quality Systems Cell and Gene Therapy Manager

hace 3 semanas


Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo

Job Summary: We are seeking a Quality Systems Cell and Gene Therapy Manager to provide technical and strategic leadership for quality systems and quality processes.

Key Responsibilities:

  • Support quality system oversight, metrics, and improvement including change control, events, CAPA, escalation, and risk management.
  • Collaborate with business partners to resolve quality issues and ensure compliant solutions.
  • Work with global quality and functional areas to ensure quality systems processes are scalable and flexible.
  • Lead process/product improvement projects and provide technical and strategic support to functional areas.

Requirements:

  • Good understanding of cGMPs in a pharmaceutical setting.
  • Ability to evaluate quality matters and make decisions using a risk-based approach.
  • Technical knowledge in risk management, quality systems, and quality governance.
  • Proven experience leading projects/teams within stated objectives and timelines.

About Vertex: Vertex is a global biotechnology company investing in scientific innovation.



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