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Associate Director of Quality Assurance - Inspections

PRA Health Sciences
Closing date
16 May 2021

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PRA has been contributing to the battle against COVID since day 1 and whilst there is no doubt that we are currently working in unprecedented times, PRA has been great at creating a sense of unity amongst our employees and globally. Our Leadership have remained dedicated to ensuring that our employees supported and productive so if you join PRA you can expect increased technology and IT support for all global home-workers as well as access to extensive health & wellbeing resources.

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What will you be doing?
  • The role is primarily inspection management and support in EU.
  • The role is responsible for leading/managing local inspections of PRA offices in EU, remotely supporting PRA teams for inspections at Sponsor offices and providing backup support to PRA teams for investigator sites inspections as required. All support is provided through the PRA project teams and not directly so there is little or no interaction with the Sponsor team/QA.
  • Performing GCP audits (mostly remote) e.g. process, vendor, some contracted audits when inspection activity is low.
  • Travel is approx. 10 to 20 % as most work can be performed remotely.

Location: Europe remote

What will you need to bring in?
  • 5+ years of experience in clinical research OR a GxP regulated environment
  • 4+ years' experience quality management or quality assurance experience in GxP environment
  • International Inspections experience is mandatory
  • Demonstrated functional management experience is highly preferred
  • Strong knowledge of GxPs (GLP, GMP, GCP); Must have demonstrated experience with GCP auditing
  • Read, write and speak fluent English
  • Bachelor's degree or equivalent in life sciences or related field is preferred
  • Additional advanced or related degree preferred
  • To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

Your health, your family, your career, your money - the things that matter to you, matter to us. The benefits of PRA just get better and better.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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