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Quality Systems Manager


  Boston, Massachusetts   Discussed on initial call

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  Quality    Permanent

Summary

Opportunity to join clinical stage combination product organisation developing life changing oncology products, where you'll have full autonomy over the Quality Management System. Joining an established team with a fully functional QMS in place, you'll take the reigns as they look to bring their awesome technology to market!

This is a remote FTE opportunity (must be based in the New England area ) paying $115,000 – $135,000

Responsibilities

  • Managing the Quality Management System under ISO:9001, ISO:13485, and 21 CFR 820.
  • Act as the subject matter expert on all CAPA, deviation, change controls, and quality documentation issues that may arise in the organisation
  • Monitor and report on relevant KPIs and metrics to assess the effectiveness of the QMS.
  • Be present during FDA audits and inspections, serving as a point of contact during key questions from regulatory bodies.

Experience Required

  • 5 years' Quality Management Systems experience across Pharmaceuticals, Biotech, or Medical Device
  • Track record of owning a eQMS, taking full responsibility and accountability for the CAPA, complaints, audit program, KPIs and defending these during an FDA audit.
  • Previous experience implementing/updating the eQMS 'Arena' is a bonus as this is the main challenge of the skilled four-person quality team (peers).

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.

Callum.Sparkes

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