Regulatory Compliance Specialist

1 week ago


Umeå, Västerbotten, Sweden Cytiva Full time

Company Overview

Cytiva, a Danaher operating company, is a global leader in life sciences and biotechnology. Our mission is to innovate for tangible impact, helping our customers solve complex challenges and bring new solutions to transform human health.

We are committed to a culture of belonging, where every individual contributes their unique viewpoint and perspective. Our goal is to create a work environment that fosters growth, learning, and collaboration.

Job Description

The QMS Compliance Lead will oversee and maintain our site Quality Management System (QMS), ensuring compliance with all relevant regulations and standards. This role involves leading compliance initiatives, providing guidance to the QA team, and collaborating with other functions at the site to uphold our quality standards.

Responsibilities

  • Maintain the site Quality Management System (QMS) in compliance with industry standards and regulations.
  • Identify areas for improvement within the QMS and implement corrective actions.
  • Collaborate with other departments to ensure quality and compliance objectives are met.
  • Participate in global QMS forums and lead local review boards.

Requirements

  • Bachelor's degree in a related field, such as Quality Management, Engineering, or Life Sciences.
  • Minimum 5 years of experience in quality management and compliance.
  • Strong knowledge of industry standards and regulations, including ISO 9001 and GMP.
  • Ability to work independently and as part of a team.
  • Fluent in Swedish and English in writing and speech.


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