R&D Quality Associate

Kingston upon Hull, East Riding of Yorkshire
Competitive Package
Sep 16, 2016
Oct 14, 2016
Result Type
Position Type
Full Time

About the role

The purpose of this position is to manage the quality assurance processes supporting clinical and consumer trials conducted by the RB Health Category.

This involves:

  • The conduct of audits to international standards of Good Clinical Practices (GCP), ISO 14155 and 13485.
  • The management (review and approval) of corrective and preventive action plans generated as a result of audits – (internal and external)
  • Support review and approval of quality management system documentation
  • Continuous improvement of the quality assurance system via management review of Quality key performance indicators
  • Actively involved in the preparation for and management of regulatory body inspections
  • Partnering with the Evidence, Consumer Safety and Medical Oversight team in order to achieve and maintain inspection readiness status
  • Provides GCP expertise, guidance and training to R&D employees

Scope/Dimensions of Role

  • Reports to the Senior Quality Associate GCP

  • Health Category covers Medicinal Products, Medical Devices, Cosmetics and General products

  • Covers clinical activities worldwide to support NPD and global roll-out of marketed products

  • Approximately  +25 medicinal product studies and +50 other product studies are supported annually


  • Ensures compliance to RB quality policies and procedures and to international standards of GCP, applicable regulatory requirements and ISO 14155 and 13485
  • Ensures that the quality assurance system is established, implemented, maintained and monitored in accordance with relevant standards
  • Conducts audits to international standards of GCP, ISO 14155 and 13485
  • Reviews and approves the corrective and preventive actions (CAPA) arising from internal/external audits
  • Assists in the investigation and resolution of system deviations and clinical trial breaches
  • Completes risk assessments on vendor management activities
  • Assists in the assessment of GCP quality system documentation such as change controls and quality SOPs
  • Provides GCP training to R&D employees
  • Is actively involved in the preparation for and the management of inspections by regulatory authorities
  • Supports implementation and oversight of  CAPA resulting from regulatory inspections and other issues that may impact quality
  • Monthly reporting of key quality performance indicators for management review
  • Updating, maintaining and improving the Quality manual with respect to GCP requirements
  • To prepare and present review of the company’s QMS to ensure it’ continued suitability, adequacy and effectiveness in conducting clinical trials

Key Challenges

  • Maintaining an excellent working knowledge of GCP , ISO 14155 and 13485 standards and regulations
  • Conducts audits which involves internal stakeholders and external providers, therefore has to influence within and outside of the organisation to a Senior level, with credibility
  • Ensures change controls are activity progressed and closed-out
  • Identifies areas of GCP risk and assists in providing workable improvements
  • Resolves quality issues to support clinical work to demanding timelines
  • Drives a continuous improvement approach to the management of the clinical processes

Professional Qualifications/Experience

  • A degree or equivalent in a relevant scientific discipline
  • Experience within a large pharmaceutical company or CRO as a quality professional
  • Excellent understanding of GCP and clinical trials regulation and compliance requirements
  • Experience in defining and maintaining a quality management system supporting clinical trial processes
  • Results oriented, entrepreneurial and self-motivated, with solid planning and organisational capabilities, a bias for action, and the capability to define, evaluate and take risks.
  • Auditor trained
  • Excellent communication skills and experience of influencing and leading cross functionally
  • Strong analytical skills with the ability to develop measurable implementation plans and able to transform solid thinking into action
  • Proven ability to work under pressure without compromising on deliverables
  • Capable of building strong working relationships to deliver outstanding results with or without hierarchical relationships.
  • As well as supporting the internal quality management system supporting the clinical trials, the role is required to support external and internal focus activities as defined below