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Job Overview

We are seeking a dedicatedQuality Specialist (0.5 FTE, 1-Year Contract)to support designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the Line Manager (LM). This part-time role is ideal for professionals who are passionate about quality assurance in clinical research and are looking to contribute their expertise in a flexible capacity.

The primary purpose of this role is to implement and tailor the global Quality Plan to meet the specific needs of the assigned scope. The Quality Specialist will assist business line staff in enhancing compliance with applicableICH-GCP, SOPs, KPIs, and relevant regulatory requirements and guidelines.

Essential Functions
• Adopt and implement the global Quality Management Plan within the scope of the assignment with the support of a mentoring Quality Manager/Senior Quality Specialist, this will include: Planning and executing the Quality Management activities. Risk identification and assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. Supporting the assigned business line management and staff to enhance effectiveness.
• Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery. Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management Plan and Risk Management Program, monitor the implementation and delivery.
• Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.
• Work in close cooperation with teams to manage non-compliance, quality issues, assist in planning corrective/preventive actions, as applicable according to SOPs. ;
• Inform the assigned business line and Quality Assurance of quality issues according to SOPs.
• Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
• May provide assistance during audits and regulatory inspections to the operational teams to the extent agreed with Quality Management and as required by the applicable SOPs.
• Prepare periodic reports to stakeholders on quality related matters, risk assessments and specific quality improvement initiatives.
• Upon agreement with the Line Manager: Perform any other reasonable tasks as required by the role.

Qualifications
• Bachelor's Degree  

• A minimum of 1 year of experience in quality assurance or regulatory compliance in the CRO or pharmaceutical industry, with at least 5 years of prior experience as a CRA.

• Preferred experience in internal/external audits and quality management.
• Strong communication and documentation skills.
• Excellent problem solving skills.
• Check compliance with GCP and relevant regulatory requirements.
• Excellent knowledge of spoken spoken and written English.

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