Senior Specialist, Clinical Quality Assurance Expert

4 weeks ago


Manchester, United Kingdom QIAGEN Full time

Overview

At QIAGEN, we're driven by a vision to make improvements in life possible. Our mission is to make a real difference in science and healthcare, and we're constantly looking for talented individuals to join our team.

Position Description

We're seeking a Senior Specialist, Clinical Quality Assurance to oversee quality and compliance for the Clinical Affairs team. This role will involve working with team members to ensure compliance during trial activities, representing Clinical QA on project teams, and supporting qualification and audits of Clinical study sites.

Key Responsibilities

  • Work with the Clinical Affairs team to ensure compliance during trial activities
  • Represent Clinical QA on project teams and perform quality reviews
  • Support qualification and perform independent QA audits of Clinical study sites
  • Participate in the QIAGEN internal audit program
  • Review Clinical Affairs SOPs

Requirements

  • Degree qualification in a relevant subject or equivalent employment experience
  • Proven working experience and knowledge of clinical regulations, standards, guidelines, and best practices
  • Demonstrable working knowledge of global In Vitro Diagnostic Regulations
  • Qualified Auditor and experience in performing as a Subject Matter Expert in regulatory inspections and audits
  • Ability to work independently and exercise good judgment and decision-making
  • Excellent communication and interpersonal skills

What We Offer

At QIAGEN, we value our employees and offer a range of benefits, including the possibility to develop in an international company, attractive pension, private healthcare, and flexible working options.



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