AdresJob Overview
Direct, oversee and coordinate assigned quality assurance programs in support of customer accounts, functional accounts, audit and inspection programs or the QA quality management system. Provide insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation and quality improvement initiatives.
Essential Functions
• Establish and maintain strong working relationships with internal and/or external customer team leads and counterparts, as assigned
• Provide actionable insights to customer counterparts, QA Leadership and Senior Management to drive quality improvements and efficiencies, and risk mitigation based on QA data analyses coupled with operational performance data and knowledge of process management, changing regulations and customer expectations.
• Provide consultation and support concerning compliance with regulations appropriate controls, quality measures and risk assessment and mitigation in the development of improved or new service offerings across the business.
• Lead and project manage internal QA quality improvement initiatives
• Plan, schedule, conduct, report and close audit activities.
• Assist in enhancement of quality assurance and control policy, and risk identification and mitigation by providing consultation and recommendations to regional and Global QA Leadership.
• Serve as author for QA SOPs. Serve as QA representative on SOP Taskforce(s) for other IQVIA functional areas as assigned.
• Participate in or lead teams for special projects as assigned. Teams may be cross functional.
• Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies.
• Host customer audits and/or regulatory inspections and participate in review of corrective action plans and effectiveness checks.
• Recommend process and systems for audit, review process and systems audit plans and oversee the delivery of these audits, review the CAPAs and ensure appropriate follow up.
• Oversee documentation, reporting, and closure of significant compliance issues.
• Support QA Leadership in proposal reviews and Reporting QA metrics and insights. Act as primary back-up for QA Leadership.
• Present trend analysis results and QA metrics and insights to senior management.
• Ensure proper coordination of customer-initiated audits and mock regulatory inspections and manage regulatory facility inspections.
Qualifications
• Bachelor's Degree
• 12 years experience Quality Assurance experience in pharmaceutical, technical, or related area including GXP Quality Assurance experience. Equivalent combination of education, training and experience.
• Extensive knowledge of the pharmaceutical research and development process, clinical research and the regulatory environment.
• Possess excellent knowledge of GxP regulations and other applicable regulations.
• Considerable knowledge of quality assurance processes and procedures.
• Knowledge of word-processing, spreadsheet, and database applications.
• Excellent interpersonal, problem solving, risk analysis and negotiation skills.
• Effective organization, communication, and team orientation skills.
• Ability to influence and guide others at all levels of management.
• Possess applicable experience in conducting audits, writing audit reports and analyzing audits.
• Demonstrated ability to lead and manage multiple responsibilities.
• Ability to work independently as well as in a team environment.
• Ability to coordinate timelines with internal customers and external vendors.
• Ability to articulate and define departmental needs and processes.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
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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