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 drive internal effectiveness reviews of internal processes/projects.
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.
Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
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.
Plan, organize, and carry out internal audit/ effectiveness checks of applicable functional areas.
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 advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
#J-18808-Ljbffr
