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Responsibilities:
• Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
• Main responsibilities will include, but are not limited to:
• Act as process and system SME for the nonconformance and CAPA process and business/system requirements
• Assist the Investigation Owner (IO) in the application of structured problem‐solving methodologies in Root Cause Analysis (RCA) investigations (Fishbone, 5 Whys, etc) independently or in support of the Root Cause Investigation team
• Coach the Investigation Owner in understanding their end-to-end accountability of the entire CAPA process
• Develop and maintain proficiency in the TrackWise ETS QEM system
• Work with the organization to identify resources to support RCA investigations and resulting actions
• Provide assistance to the record owner to ensure process requirements are met
• Monitor nonconformance and CAPA deliverables / timelines for functional area by running reports, communicating upcoming deadlines to record owners and escalating concerns to management as appropriate to actively drive compliance
• Act as a liaison between the record owner and the quality leader; the record owner and the Root Cause Analysis group; the record owner and the TrackWise central entry team.
• Escalate any issues, as needed, to the BRQC CAPA Review Board
• Raise any process or system questions or concerns to the CAPA Champions Community of Practice
• Manage requests for assistance from the TrackWise central data entry team on behalf of the IO

Education and Experience Requirements/Qualifications:

• A minimum of a Bachelor’s degree in Science (BSc) or Arts (BA), or 6–8 years of relevant experience is required.
• At least 6 years of experience in the pharmaceutical industry, with 3–4 years of GxP experience in clinical research, development, or quality assurance.
• Experience in Quality Control and Compliance, Quality Assurance, CAPA processes, and/or Root Cause Analysis.
• Knowledge of the overall drug development process.
• Strong understanding of business processes and practices, including SOPs governing clinical research activities.
• Experience in quality assurance activities, such as audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions.
• Ability to translate data into actionable insights and develop executable strategies.
• Strong conflict resolution, negotiation, and stakeholder motivation skills.
• Ability to independently plan, organize, and manage tasks.

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