Senior Quality Leader

3 weeks ago


Reston, Virginia, United States Enigma Search Full time

The Senior Quality Leader will provide strategic leadership for all Quality functions and report directly to the CEO. This role will focus on developing and maintaining best-in-class Quality Control and Quality Assurance teams. The Senior Quality Leader will be based in the US and will sit on the senior leadership team.

Key Responsibilities:

  • Develop, implement, and oversee a comprehensive quality strategy and roadmap aligned with Company goals and growth objectives.
  • Lead, manage, and develop the Quality Control and Quality Assurance teams to deliver high performance and efficiency to meet company goals.
  • Ensure productive quality management systems, processes, and procedures aligned with compliance and risk best practices.
  • Partner with cross-functional teams to ensure quality best practices and procedures are embedded in all GDMP and R&D activities.
  • Conduct risk assessments and audits and advise on necessary improvements and adjustments as needed.
  • Serve as the primary point of contact for quality-related matters for internal and external parties.

Requirements:

  • 10+ years of experience as a senior Quality Leader with extensive professional understanding of both Quality Control and Quality Assurance best practices.
  • Deep understanding of GMP, quality systems, and regulatory best practices from early-stage clinical development through commercial approval.
  • Extensive experience as a strategic leader with ability to lead, develop, and grow teams.
  • Experience at a growth stage company with the ability to be both a strategic and a hands-on leader.
  • Strong communication skills and ability to connect with internal and external stakeholders.


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