Senior QA Auditor - GCP Audits

IQVIA; Indianapolis (IN); On-site; USD 75,000 - 189,000; Full time

Job summary

IQVIA in Indianapolis, IN seeks an experienced QA auditor to plan and conduct independent GCP audits across IQVIA contracts worldwide. You will prepare reports, advise project teams, and support management in regulatory compliance and process improvements.

The role requires 5+ years in pharma/quality, travel 30-50%, and strong analytical and interpersonal skills to guide CAPA and corrective actions.

Qualifications

• Bachelor's Degree preferred.
• Travel 30-50%.
• 5 years experience in pharmaceutical, technical, or related area, with 3 years in Quality.
• Assurance Audits; GCP experience.
• Experience in clinical trial investigator site audits.
• Experience in clinical study report/data management/biostatistics audits preferred.
• Knowledge of word-processing, spreadsheet, and database applications.
• Strong knowledge of pharmaceutical R&D processes and regulatory environments.
• Knowledge of quality assurance processes and procedures.
• Strong interpersonal, problem solving, risk analysis and negotiation skills.

Responsibilities

• Plan, schedule, conduct, report and close audits per IQVIA contracts.
• Evaluate audit findings and prepare reports for stakeholders.
• Provide interpretation of regulations, guidelines, and procedures to teams.
• Assist in corrective action plans and CAPA tracking.
• Review investigations, RCA, CAPA and EC plans and track closure.
• Maintain eQMS and support audit lifecycle activities.
• Lead or collaborate on QA initiatives and training.
• May manage quality issues and present educational programs.

Skills

GCP auditing

Quality Assurance

Regulatory compliance

Investigator site audits

Interpersonal skills

Analytical skills

Education

Bachelor's degree

Tools

Office software

eQMS

Word processing / spreadsheets / databases

Job description

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.

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.