Job Overview
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.
Essential Functions
• 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
Qualifications
• Bachelor's Degree Pref
• 15 years of Program, Project Management Experience
• 5 years of exposure to Quality Assurance in pharmaceutical, or compliance area, including GCP Quality Assurance experience. 3 years of management experience. Equivalent combination of education, training, and certification.
• 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.
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