Senior QA Auditor – GCP Audits

IQVIA

. Plan, schedule, conduct, report and close audit activities in countries involved with IQVIA contracts .

Posted 9/24/2026full-timeUnited StatesSenior💰 $75,400 - $188,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive knowledge of Quality Assurance processes, regulatory compliance, and pharmaceutical research and development. Capable of conducting audits, managing quality issues, and providing training while maintaining effective communication and collaboration with project teams and clients.

Highest-signal resume keywords

Quality Assurance AuditsGCP ExperienceClinical Trial AuditsRoot Cause AnalysisRegulatory Compliance

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Quality Assurance ProcessesAudit Lifecycle ManagementData ManagementBiostatisticsProcess ImprovementRegulatory Environment KnowledgeCAPAEffectiveness CheckInvestigator Site AuditsContinuous Process Improvements

Soft Skills

Interpersonal SkillsProblem SolvingRisk AnalysisNegotiation SkillsTraining CapabilitiesOrganizational SkillsCommunication SkillsTeam Orientation

Tools & Technologies

Electronic Quality Management SystemWord-Processing ApplicationsSpreadsheet ApplicationsDatabase Applications

Industry Keywords

PharmaceuticalClinical TrialsRegulatory InspectionsCompliance ProceduresAudit Observations

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Plan, schedule, conduct, report and close audit activities in countries involved with IQVIA contracts
Assess compliance with 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, policies, and procedures
Consult customers and monitors on audit observations and corrective action plans
Review and approve investigations, Root Cause Analysis, CAPA, and Effectiveness Check plans, and track them to closure
Evaluate policies and procedures and recommend continuous process improvements
Maintain the electronic quality management system and support the audit lifecycle
Lead, collaborate on, and support quality assurance initiatives and process improvement projects
Assist in training new Quality Assurance staff
Manage Quality Issues as required
Present educational programs and guide operational staff on compliance procedures as required
Perform pre-inspection visits, host audits/inspections, ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections as assigned

Requirements

What you’ll need

Bachelor's Degree preferred
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
Travel 30-50%

Benefits

Comp & perks

Incentive plans, bonuses, and/or other forms of compensation may be offered
Health and welfare benefits may be offered
Equal opportunity employment