QA Manager

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IQVIA

WebsiteLinkedInAll Job Openings

10,000+ employees

⚕️ Healthcare Insurance

🧬 Biotechnology

🤖 Artificial Intelligence

💰 $1G Post-IPO Debt on 2023-05

Healthcare Insurance • Biotechnology • Artificial Intelligence

IQVIA is a global leader in data analytics and technology solutions, dedicated to improving health outcomes. The company utilizes its Connected Intelligence platform to harness the power of advanced data analytics and artificial intelligence, facilitating innovation in healthcare. IQVIA focuses on various areas, including clinical research, technology, and consulting services to solve complex healthcare challenges and accelerate the delivery of new therapies to patients.

📋 Description

• 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 support to management with 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. • Manage the quality assurance oversight of projects, assignments, training and staff. • Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies. • Oversee and participate in the documentation, reporting, and closure of compliance issues. • Organize and deliver training to other IQVIA departments concerning the activities of Quality services, results of activities, quality initiatives, GXP etc. • Ensure the follow-up of major and critical audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified. • Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements. • Serve as author of Quality Assurance Standard Operating Procedures (SOPs) as assigned. • Advise Quality Assurance management on system audit needs. • Ensure the Quality Assurance database is maintained and up-to-date to reflect the status of audits being scheduled, auditor assignment and audit reporting and/or follow-up status. • Host customer audits, mock regulatory inspections, and regulatory facility inspections as needed.

🎯 Requirements

• Bachelor’s degree in Life Sciences • Clinical Research background with extensive knowledge of pharmaceutical research and development processes and regulatory environments. • +4 years Quality Assurance experience in pharmaceutical, technical, or related area. • Considerable knowledge of quality assurance processes and procedures. • Knowledge of word-processing, spreadsheet, and database applications. • Experience in audits/inspections is a plus • Advanced English level • Strong interpersonal and communication skills. • Excellent problem solving, risk analysis and negotiation skills. • High tolerance to stress; calm and composed demeanor • Exceptional training capabilities. • Effective organization, team orientation, and leadership skills. • Ability to work independently with initiative. • Ability to manage multiple projects.

🏖️ Benefits

• Full remote role with occasional travel: 20–30% per year