• Manager of Quality Assurance - Regulatory Inspections

    Job Locations (All) | Germany | Spain | France | United Kingdom | Italy | EU-Remote
    Posted Date 7 months ago(3/28/2018 9:18 AM)
  • Overview

    At PRA, we don’t make our 15000+ people great. It’s the other way around. As we have grown to a top-5 CRO, we have maintained the feel of a small company, dedicated to collaboration and passion for what we do.


    We always have a desire to keep seeking new and better ways to operate. We don’t settle for the same old ways. Our passion for improving patient lives worldwide permeates all that we do. Put simply, we care.


    We are looking for a Manager of Quality Assurance with a keen interest and passion to inspection management in Europe. 


    Responsibilities of this challenging role include but are not limited to preparation, guidance and follow-up of inspections audits. You will work closely with internal PRA groups to manage overall inspection, quality and compliance activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations.


    Still interested? Great, there’s more…

    · Organizing and managing the department activities to ensure an optimal realization of corporate policies.

    • Provide direction, guidance and leadership.
    • Review information and results.
    • Intervene when problems arise.

    · Stay informed and maintaining a respected status within discipline.

    • Stay informed of developments in the field of quality, compliance, quality assurance, by reading professional literature, participating in symposia etc.
    • Participate in meetings and meetings of quality and compliance associations.
    • Participate in giving external and internal quality training

    · Continuous improvement of the quality of the products within CRO.

    • Initiate and participates in working groups and project teams regarding quality improvement programs.
    • Advise in case of quality problems (troubleshooting).
    • Provide information to employees about inspections, audits, procedures (SOPs), regulations etc.


    Location: This position can be home-based in Europe.


    The ideal candidate will have the following:

    • Experience with compliance, auditing and SOP development in a CRO or pharma environment
    • Senior management experience in inspection readyness, compliance or auditing 
    • Thorough understanding of GCP, GXPs and EC and/or US regulations
    • Understanding of all aspects of clinical research, including protocol development, CRF design, clinical trial management (including laboratory methodologies ad clinical examinations), data management, statistical analysis, clinical study reports, and regulatory submissions
    • Read, write and speak fluent English;fluent in host country language required.  Fluency in other languages is a plus.
    • An undergraduate degree or its international equivalent from an accredited institution required. Preferably in the health-sciences or computer sciences.


    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.



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