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Remote Opportunity
Job Overview
This QA Manager is a member of the CAPA Excellence Center, and will lead and support effective corrective and preventive action (CAPA) management for significant quality issues (QIs) and audit and inspection responses including the assessment and review of investigations, appropriate root cause analysis and corrective and preventative actions. Provide support to management with insights, analyses and assessment and promotion of compliance with regulations, guidelines, and operating procedures through risk identification and mitigation, and improvement initiatives. Manage the quality assurance oversight of quality issues, audit responses, assignments, training and staff. Oversee and lead team management activities.
Essential Functions
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Lead and mentor members of the CAPA management team, with a focus on driving improvement and compliance, ensuring an aligned approach to CAPA management and adherence to regulations and guidelines and providing support as needed.
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Lead and support CAPA activities for complex QIs and sponsor audits and inspections: assessing investigations, ensuring appropriate root cause analysis is performed, adequate corrective and preventative actions and effectiveness are implemented and followed up within the agreed timelines
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Collaborate with cross-functional stakeholders to identify process gaps, areas of improvements and ensure the application of quality processes, principles and strategy to support compliance with relevant regulations, GCP guidelines, procedures and sponsor agreements
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Ensure proper reporting and documentation of CAPAs in the electronic quality management system (eQMS) and that robust corrective and preventative actions and effectiveness checks are tracked and completed within the required timelines
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Promote a culture of proactive and continuous process improvement by identifying risks and trends, and optimizing the CAPA system and processes.
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Lead with a spirit of teamwork and collaboration to ensure effective communication among all department stakeholders and staff.
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Develop and/or provide training and guidance on Root Cause Analysis (RCA), CAPA management, execution, good documentation practices, and compliance adherence
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Develop and/or improve governing procedures, templates and work instructions, in order to streamline processes and drive compliance .
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Advise Quality Assurance management on system audit needs. Support external and internal audits and inspections of IQVIA including inspections of IQVIA or investigational sites where needed, and ensure a state of inspection readiness at all times
Required Experience
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Bachelor’s Degree Preferred
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7 years of Quality Assurance experience in the Pharmaceutical, Biotech or CRO industry, with a focus on Deviations/Non-Conformances/CAPA Excellence within Clinical Trials; GCP and/or GVP (Not GMP or GLP)
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5 years of Direct Line Management experience.
Preferred Experience :
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A background in science or healthcare
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Experience preparing, supporting and participating in Audit/Inspections
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Experience writing audit/inspection responses
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Extensive knowledge of CAPA Management, GCP Guidelines, The Clinical Trials Process and Relevant regulations for the conduct of clinical trials
Skills and Abilities
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Knowledge of word-processing, spreadsheet, and database applications.
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Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
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Considerable knowledge of quality assurance processes and procedures.
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Strong interpersonal skills.
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Excellent problem solving, risk analysis and negotiation skills.
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Exceptional training capabilities.
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Effective organization, communication, team orientation, and leadership skills.
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Ability to work independently with initiative.
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Ability to manage multiple projects.
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Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Department Summary
The IQVIA QA team is a dynamic, talented, and experienced global team that owns the global quality management system for the largest human data science company in the world. The QA function is responsible for driving compliance in a highly regulated industry through audits, hosting customer audit and regulatory inspections, functional support, issue & CAPA management, regulatory consultancy, management of data analytics and customer relationship interactions. These services ensure our clinical research activities are of the highest quality. We proactively support our business partners and help to drive innovation. Continuous improvement is a core capability and we value strategic thinking, creativity and operational excellence. We seek highly motivated people who truly want to make a difference in the life sciences industry and are looking for opportunities to impact the business and be part of the solution. At IQVIA, we support our colleagues with a focus on succession planning, career progression and continuous learning.
#LI-Remote #AmberPippin
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
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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