IQVIA · 19 hours ago
Senior QA Auditor - GCP Audits
Durham, NC
Full-time
Remote
Senior Level
$91K/yr - $152K/yr
5+ years exp
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Responsibilities
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.
Qualification
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Required
Bachelor's Degree
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.
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.
Preferred
Experience in the conduct of clinical study report/data management/biostatistics clinical trial audits.
Benefits
Incentive plans
Bonuses
Health and welfare and/or other benefits
Company
IQVIA
IQVIA provides analytics, compliance, and management solutions to the life sciences industry.
10,001+ employees
H1B Sponsorship
IQVIA has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (218)
2022 (199)
2021 (286)
2020 (197)
Funding
Current Stage
Public CompanyTotal Funding
$1.5B2023-11-14Post Ipo Debt· $500M
2023-05-18Post Ipo Debt· $1B
2019-08-08Post Ipo Equity· undefined
Leadership Team
Chris Colapietro
Vice President, Customer Engagement
Christina Bodurow
Vice President, Global Regulatory Affairs
Recent News
2024-10-31
The Pharma Letter
2024-05-29
2024-05-05
Company data provided by crunchbase
