Sr Quality Specialist

(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

Please note this role is not eligible for UK Visa sponsorship.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.