Clinical FSP Quality Manager

Job Overview

This role is an individual contributor 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 work together with operations, global or regional Quality Management team(s), functional teams, customer and other stakeholders in a joint effort to adopt the Quality Plan, Standard Operating Procedures (SOPs), improving compliance to International Council for Harmonization (ICH), Good Clinical Practice (GCP), Key Performance Indicators (KPIs), applicable regulatory requirements, and guidelines. This role provides advice and supports clinical staff and other relevant key stakeholders with regard to risk identification / management, proactive quality control and corrective / preventive actions upon issues arise.

Essential Functions

• Adopt and implement the global Quality Management Plan within the scope of the assignment, 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, support in planning corrective / preventive actions, as applicable according to Standard Operating Procedures (SOPs.); Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.

Qualifications

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities / Females / Protected Veterans / Disabled