We are seeking a Senior Quality Assurance Auditor to join Q² Solutions, IQVIA’s laboratory business in Durham, NC .

We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development.

As a Senior Quality Assurance Auditor, you will plan and conduct independent audits to assess compliance with regulations, guidelines, and operating procedures. You will also prepare and distribute reports of findings to supervisors, operations staff, management, and customers.

What you’ll be doing:

• Planning, scheduling, conducting, reporting, and closing audit activities in any of the countries involved with IQVIA contracts.

• Evaluating audit findings and prepare and distribute reports to operations staff, management, and customers.

• Providing interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.

• Managing Quality Issues and present educational programs to operational staff on compliance procedures.

• Reviewing, approving investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans.

• Providing quality assurance consultancy activities and projects for clients within budget and established timelines.

• Hosting audits/inspections, ensuring proper conduct of customer-initiated audits and mock regulatory inspections, and assisting in regulatory facility inspections.

• Assisting in training of new Quality Assurance staff.

What We Are Looking For:

• Bachelor’s Degree Preferred

• 5 years’ experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance. GXP experience.

• Knowledge of word-processing, spreadsheet, and database applications.

• Extensive knowledge of pharmaceutical research and development processes and regulatory environments.

• Other Equivalent combination of education, training, and experience may be accepted in lieu of degree.

The Knowledge, Skills and Abilities needed for this role:

• Knowledge of quality assurance processes and procedures.

• Strong interpersonal skills.

• Excellent problem solving, risk analysis and negotiation skills.

• Strong training capabilities.

What We Offer You:

We put our employees at the center of everything we do and are committed to providing them, and their families, with benefits that meet their diverse and changing needs. We invest in integrated benefits programs and resources to take care of our employees’ physical, mental, and emotional, financial, and social well-being so they can thrive at home and at work, at any stage of their well-being journey.

To learn more about our benefits, visit https://jobs.iqvia.com/benefits .

If you’re looking to unleash your potential, join Q² Solutions, IQVIA’s laboratory business, to help make the extraordinary possible!

Q² Solutions, IQVIA’s laboratory business, creates connected intelligence by combining our expertise, technology and analytics - this fuels unparalleled research & development solutions. We uphold a deep commitment to patients, sites, customers, and each other. https://www.q2labsolutions.com/careers

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe

Q² Solutions’ ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-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.

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – 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 Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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