Provide 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. 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. Act as line manager for one or more QA staff and oversee development and departmental deliverables. Manage the quality assurance oversight of projects, assignments, training and staff.
• Plan, schedule, conduct, report and close audit activities, as assigned
• Provide Quality Assurance support, guidance and management of Quality Issues, as assigned
• Assist in the enhancement of Quality Assurance and control policy, and risk identification and mitigation by providing consultation & recommendations to regional and Global QA Management
• Serve as an author for QA Standard Operating Procedures (SOPs), and act as regional QA representative to the global QA SOP taskforce
• 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 participate in review of corrective action plans,as assigned
• Recommend systems for audit, write systems audit plans, coordinate scheduling, conduct, reporting and closure of internal system audits
• Serve as the QA Contact for assigned internal/external customers and IQVIA functional areas
• Oversee documentation, reporting, and closure of compliance issues
• Support Quality Management in proposal reviews and reporting QA metrics
• Conduct trend analysis of audit results, provide to internal/external stakeholders as agreed, as assigned
• Oversee proper coordination of customer-initiated audits and mock regulatory inspections, manage regulatory facility inspections, as assigned
• Participate in or lead (cross functional) teams for special projects as assigned
• Promote the concept of quality, the principles of quality management and devise and implement quality improvements
• Manage staff, including planning, assigning, & directing work, appraising performance, guiding professional development, rewarding and disciplining employees, addressing employee relations issues & resolving problems. Approve actions on human resources matters
• Bachelor's Degree
• 10 years Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience. 3 years of management experience. Equivalent combination of education, training and experience.
• Knowledge of word-processing, spreadsheet, and database applications.
• Strong knowledge of pharmaceutical research and development processes and regulatory environments.
• Considerable knowledge of quality assurance processes and procedures.
• Strong interpersonal skills.
• Excellent problem solving, risk analysis and negotiation skills.
• Effective organization, communication, and team orientation and leadership skills.
• Ability to influence and guide others.
• Ability to manage costs effectively through appropriate resource allocation.
• Management experience in Quality Assurance.
• 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 – 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 jobs.iqvia.com.