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Job Details


Company: PRA Health Sciences
Location: Europe
Reference: AB-2017-42020
Closing Date: 03 Sep 17
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary and Benefits

Job Summary:

An outstanding opportunity to join one of the world’s leading contract research organisations and be part of a dynamic and growing international company. Join PRA Health Sciences as a Associate Director of Quality Assurance and help realize your career potential.



Location: Europe (Poland, Slovakia, Czech Republic, Hungary, Serbia, Bulgaria, Netherlands, United Kingdom, Germany)                

 As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 70+ such drugs.

At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.

At PRA, borders do not create boundaries.  PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals.  Our growing workforce is comprised of over 13,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community

For more information please see our website:


We are currently recruiting an Associate Director Quality Assurance focusing on our GMP QA activities in Eastern Europe.

This position assists in ensuring the company promotes a culture that encourages ethical conduct and a commitment to compliance, resulting in a positive image internally and to customers. This is a cross functional role that interacts with all functions of the organization.

Assists QA Management or acts as deputy with respect to:

  • Provides clear strategic and functional direction and team and individual goals and expectations to ensure each QA staff member understands her/his responsibility to know and follow all SOPs and corporate policies
  • Ensures QA staff under their direction effectively executes the QA Operating Plan, including the annual audit plan, approved by senior management
  • Ensures all contracted operational and systems audits are planned, schedule, performed and results reported and documented in adherence to protocols, SOPs, regulations, GxP, and expectations for data accuracy and completeness
  • Defines future work methodologies to better meet customer needs
  • Broadly and globally interprets regulations and guidance documents governing GxP and serves as expert and consultant to PRA stadd and client representatives
  • Ensures all new and updated PRA SOPs are reviewed by QA for clarity, internal consistency and compliance with global GxPs
  • Ensures client audits and regulatory inspections of PRA are prepared and hosted to meet the client’s/inspectors’ requirements and minimize disruptions to ongoing operations
  • Actively participates in the reviewing and hiring of new QA staff and ensures new QA employees are trained and qualified to perform their tasks
  • Provides regular status reports on quality observations to Operational Management, as requested
  • Contributes to training for selected PRA functional groups related to Good Clinical Practice, clinical trials regulations, and the role of QA and PRA staff in ensuring compliance with GCP
  • Mentors and develops new QA managers
  • Leads the evaluation and management of escalations related to persistent or serious misconduct
  • Participates in and/or leads, as assigned, GxP related projects initiated by internal stakeholders

Other responsibilities may include:

  • Oversight of Quality Assurance Tracking System to ensure that reporting, tracking, trending and analysis of non-compliance issues is performed as required
  • Management, trending and analysis of internally and externally reported non-compliance issues
  • Interactions with various PRA functions to determine needs for process improvement, corrective and preventive actions and risk based auditing approach resulting from trending activities

Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scale.

If you have any questions please email or call our recruitment department at +44 (0) 1189 213652

PRA Health Sciences is an Equal Opportunity Employer.  We welcome and encourage diversity in the workplace.


Contact Information:

Address:  Head Office
500 South Oak Way
Green Park
Tel:  +44 (118) 918 1000
Fax:  +44 (118) 918 1001
Website:  Visit Our Web Site

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