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 global or regional Quality Management team(s), functional teams, and other stakeholders in a joint effort to clearly define the global Quality Plan, carry out, and adopt the plan according to the specific needs defined by the scope of assignment, assist staff in improving compliance with relevant International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), 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 quality control, risk management, and corrective/preventive actions.

Essential Functions

• Adopt and implement the global Quality Management Plan within the scope of the assignment, including planning and execution of quality management activities; risk identification and assessment through data review and quality control processes; providing support in risk mitigation, planning corrective/preventive actions and guidance for improvement; supporting the assigned business line management and staff to enhance effectiveness.
• Cooperate closely with relevant business and other stakeholders, supporting maintaining focus on quality in project delivery.
• Contribute to development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program, monitoring implementation and delivery.
• Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of GCP compliance.
• Work in close cooperation with teams to manage non‑compliance and quality issues, supporting in planning corrective/preventive actions according to SOPs.
• Inform Quality Management, 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.
• Provide assistance during audits and regulatory inspections to the teams to the extent agreed with the business lines, as required by SOPs.
• Act as the primary contact for Quality Assurance on quality matters – at the level of the assignment, attend meetings/teleconferences.
• Prepare periodic reports to business lines 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

• Bachelors Degree or equivalent qualification.
• Equivalent combination of education, training, and experience.
• 3‑4 years of GCP and quality management experience is a must.
• Knowledge of CRO industry operations.
• Experience working in a client‑facing role is a big plus.
• Good judgement and decision‑making skills.
• Strong influencing and negotiation skills.
• Strong computer skills including Microsoft Office applications.
• Excellent problem‑solving skills.
• Ability to lead and motivate a clinical team.
• Ability to establish and maintain effective working relationships with co‑workers, managers and clients/customers.
• Fluent in 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

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.

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