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Job Overview

(this role is fully home-based)

We are seeking an experienced Quality Manager to oversee & coordinate assigned Quality Management system program elements in support of Patient Centered Solution functional areas, internal effectiveness review processes, audit support, and overall support of a healthy quality management system. This role shall participate in promotion of compliance with regulations, guidelines, internal written procedures, risk identification and continuous improvements initiatives.

Responsibilities

·Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, standard operating procedures, and policies.

·Further develop, maintain and execute internal effectiveness reviews including collaboration with key leadership on scheduling. Execute reviews by reviewing procedural content, objective evidence and regulatory requirements.

·Oversee and participate in the documentation, reporting, and closure of compliance issues.

·Organize and deliver training to other IQVIA departments concerning the activities of Quality services, results of activities, quality initiatives, GXP etc.

·Ensure the follow-up of audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified.

·Support root cause analysis and action planning for internally and externally identified quality issues.

·Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.

·Identify areas of non-conformance or need for improvement within the quality management system. Propose modifications to the quality management system, obtain leadership buy in and execute per agreement.

·Write and revise quality management procedures as required.

·Support assessing, mitigating risks identified within the applicable functional areas.

·Define and solution efficiency and process improvements that will benefit multiple functions within the organization.

·Participate in off the shelf software validation and risk assessment activities.

·Support client audit readiness and audit execution.

Qualifications

·Bachelor's Degree or equivalent working experience within regulated life science industries.

·7 years Quality Management experience in pharmaceutical, medical device, technical, or related area. Equivalent combination of education, training and experience.

·Extensive knowledge and aligned experience with internal auditing.

·Knowledge of software development processes and GAMP5 requirements.

·Knowledge and experience within a GCP regulated industry.

·Considerable knowledge of quality management processes and procedures

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