Job OverviewProvide insight which is exercisable across the large part of the organization or by managing a team of managers by influencing outcomes.
Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and / or global level.
Â Provide insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation, quality, process, productivity / efficiency improvement initiatives.
Â Â Â Manage the quality assurance oversight of projects, assignments, training and staff.Essential Functionsâ ¢ Plan, schedule, conduct, report and close audit activities, as assignedâ ¢ Provide Quality Assurance support, guidance and management of Quality Issues, as assignedâ ¢ Assist in the enhancement Â of Quality Assurance and control policy, and risk identification and mitigation by providing consultation & recommendations to regional and Global QA Managementâ ¢ Serve as an author for QA Standard Operating Procedures (SOPs), and act as regional QA representative to the global QA SOP taskforceâ ¢ Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policiesâ ¢ Host customer audits and participate in review of corrective action plans,as assignedâ ¢ Recommend systems for audit, write systems audit plans, coordinate scheduling, conduct, reporting and closure of internal system auditsâ ¢ Serve as the QA Contact for assigned internal / external customers and IQVIA functional areasâ ¢ Oversee documentation, reporting, and closure of compliance issuesâ ¢ Support Quality Management in proposal reviews and reporting QA metricsâ ¢ Conduct trend analysis of audit results, provide to internal / external stakeholders as agreed, as assignedâ ¢ Oversee proper coordination of customer-initiated audits and mock regulatory inspections, manage regulatory facility inspections, as assignedâ ¢ Participate in or lead (cross functional) teams for special projects as assignedâ ¢ Promote the concept of quality, the principles of quality management and devise and implement quality improvementsQualificationsâ ¢ Bachelor's Degree Â Reqâ ¢ 10 years experience Quality Assurance experience in pharmaceutical, technical, or related area including Â GXP Quality Assurance experience.
Equivalent combination of education, training and experience.â ¢ Knowledge of word-processing, spreadsheet, and database applications.
â ¢ Strong knowledge of pharmaceutical research and development processes and regulatory environments.â ¢ Considerable knowledge of quality assurance processes and procedures'.
â ¢ Strong interpersonal skills and the ability to positively influence and guide others.â ¢ Excellent problem solving, risk analysis and negotiation skills.
â ¢ Effective organization, communication, and team orientation and leadership skills.â ¢ Possess applicable experience in conducting audits, writing audit reports and analyzing audits.
â ¢ Demonstrated ability to lead and manage multiple responsibilities.â ¢ Identify functional constraints and identify solutions.
â ¢ Ability to coordinate timelines with internal customers and external vendors.â ¢ Ability to manage multiple activities and timelines.
â ¢ Ability to articulate and define departmental needs and processes.â ¢ Ability to establish and maintain effective working relationships with coworkers, managers and clients.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible â to help our customers create a healthier world.
The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.
Learn more at IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare â and human health â 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 QÂ² Solutions, contributes to our shared goal of improving human health.
Thank you for your interest in growing your career with us.EEO Minorities / Females / Protected Veterans / Disabled