Sr Quality Specialist

Job Overview

(CRAs are encouraged to apply)

This role is assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the Line Manager (LM). The purpose of this role is to implement and adapt the Global Quality Management Plan in alignment with the specific needs of the assigned scope.

The CCQM supports business line staff in improving compliance with International Conference on Harmonisation (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, Standard Operating Procedures (SOPs), and Key Performance Indicators (KPIs).

The role also contributes to the development and implementation of quality improvement initiatives and provides guidance on quality control, risk assessment, risk management, and corrective and preventive actions (CAPA).

Key Responsibilities

• Implement and execute the Global Quality Management Plan within the assigned scope, including:

  • Planning and conducting quality management activities
  • Performing risk identification and assessment through data review and quality control processes
  • Supporting risk mitigation and CAPA planning
  • Providing guidance to improve quality and operational effectiveness

• Collaborate closely with business lines and key stakeholders to ensure strong focus on quality in project delivery

• Provide expert advice and support on GCP compliance to assigned teams and stakeholders

• Support the management of non-compliance and quality issues in accordance with SOPs

• Develop, track, follow up, and ensure timely closure of CAPAs

• Identify and escalate serious quality issues in a timely manner

• Inform relevant business lines and Quality Assurance (QA) teams of quality issues per SOP requirements

• Partner with QA and business teams in cases of suspected misconduct as required

• Support audit and regulatory inspection readiness and participate as agreed

• Conduct quality control visits as required (primarily for unblinded studies where applicable)

• Prepare periodic reports on quality metrics, risks, and continuous quality improvement initiatives

• Deliver training and knowledge-sharing sessions to local teams, as applicable

• Perform additional tasks as assigned by the Line Manager

Qualifications & Experience

• Bachelor’s degree (required)
• Minimum 4 years of clinical research experience, including monitoring experience (e.g., CRA background)
• Experience in quality management or quality oversight is an advantage
• Experience participating in audits and regulatory inspections
• Experience delivering or contributing to training activities (primarily internal teams)

Working Model & Additional Information

• Hybrid working model: office-based and home-based
• Expected presence in the office approximately 2-3 days per week
• Office location: Moorgate, London
• Some travel to site may be required for quality control visits depending on study allocation