Senior QA Auditor - GCP Audits

IQVIA; Durham (NC); On-site; USD 75,000 - 189,000; Full time

Job summary

IQVIA is seeking a QA Audit professional in Durham, NC to plan and conduct independent clinical (GCP) audits. The role involves reporting findings to supervisors and customers, interpreting regulations, and supporting management in QA initiatives.

The candidate will review investigations, RCA, CAPA plans, and track closure, while maintaining the eQMS and guiding QA activities across multiple projects. Travel 30-50% is expected.

Qualifications

• Bachelor's degree preferred; 5 years in pharma/related area with 3 years in Quality.
• Willingness to travel 30-50%.
• Experience in GCP audits and clinical trial audits.
• Knowledge of QA processes and regulatory environments.
• Strong interpersonal, negotiation, and training skills.

Responsibilities

• Plan, schedule, conduct, report and close audit activities across IQVIA contracts.
• Evaluate findings and prepare reports for operations, management and customers.
• Provide interpretation of regulations, guidelines, policies, and procedures.
• Support customers and monitors in interpretation of audit observations and corrective action plans.
• Review and approve RCA, CAPA and EC plans; track to closure for quality events.
• Maintain eQMS and support audit lifecycle activities.
• Lead or support QA initiatives and training for staff.
• May present educational programs to operational staff on compliance.

Skills

GCP audits

Risk analysis

Project management

Communication

Team collaboration

Independent work

Education

Bachelor's degree

Tools

MS Word

Excel

Databases

Job description

Durham, North Carolina, United States of America

Full time

R1527130

Overview:

Plan and conduct independent clinical (GCP) audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.

Essential Functions :

• Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions
• Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers
• Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures
• Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans
• Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closure for quality events arising from Audits; and from Quality Issues, Inspections or during similar QA activities as assigned.
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
• Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle
• Lead/collaborate/support in QA initiatives/projects for quality, process improvements
• Assist in training of new Quality Assurance staff
• May be required to manage Quality Issues
• May present educational programs and provide guidance to operational staff on compliance procedures
• May perform pre-inspection visits at sites, host audits/inspections; ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections, as assigned.

Qualifications:

• Bachelor's Degree Pref
• Travel 30-50%
• 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality
• Assurance Audits. GCP experience. Equivalent combination of education, training and experience.
• Experienced in the conduct of clinical trial Investigator site audits.
• Experience in the conduct of clinical study report/data management/biostatistics clinical trial audits is preferred.
• Knowledge of word-processing, spreadsheet, and database applications.
• Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
• Knowledge of quality assurance processes and procedures.
• Strong interpersonal skills.
• Excellent problem solving, risk analysis and negotiation skills.
• Strong training capabilities.
• Effective organization, communication, and team orientation skills.
• Ability to initiate assigned tasks and to work independently
• 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 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

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $75,400.00 - $188,600.00. 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 leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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