Quality Assurance Manager, Hybrid - Durham, North Carolina

Job Overview :

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.

Host onsite (Durham) and remote audits. 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, and training.

Essential Functions :

• Host customer audits, mock regulatory inspections, and regulatory facility inspections as needed
• 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.

Qualifications :

• Bachelor's Degree Preferred
• 7 years Quality Assurance experience in pharmaceutical, technical, or related area. Equivalent combination of education, training and experience.
• Experience in GCP Quality Assurance.
• Experience hosting audits onsite and remotely.
• Knowledge of word-processing, spreadsheet, and database applications.
• Extensive 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.
• Exceptional training capabilities.
• Effective organization, communication, team orientation, and leadership skills.
• Ability to work independently with initiative.
• Ability to manage multiple projects.
• 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

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.

The potential base pay range for this role, when annualized, is $91,100.00 - $151,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience;

location; and / or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and / or other forms of compensation may be offered, in addition to a range of health and welfare and / or other benefits.