Quality Operations Lead

5 days ago


Burlington, Massachusetts, United States Vericel Corporation Full time

About the Role

We are seeking an experienced Quality Operations Lead to join our team at Vericel Corporation. As a key member of our quality department, you will be responsible for ensuring the quality and compliance of our medical device products. This includes partnering with manufacturing and supply chain teams to ensure compliance and business targets are met.

The ideal candidate will have a strong understanding of Medical Device Regulations and cGMP systems, as well as excellent leadership and communication skills. A minimum of 8 years of industry experience is required, including prior Quality leadership roles. A bachelor's degree is preferred, or a master's degree plus 6 years of relevant experience.

Responsibilities

  • Provide guidance and ensure commercial manufacturing operations (CMOs) are performed in compliance with cGMP.
  • Partner with manufacturing and supply chain to ensure compliance and business targets are met.
  • Ensure the batch disposition process is robust.
  • Support process improvements and streamlining in collaboration with department team.
  • Drive culture of compliance and openness.
  • Set ambitious and achievable targets to drive for results based on organizational objectives.

Estimated Salary Range: $130,000 - $190,000 per year

If you are a motivated and detail-oriented professional with a passion for quality assurance, we encourage you to apply for this exciting opportunity to join our team at Vericel Corporation.



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