The IQVIA QA team is a dynamic, talented, and experienced global team that owns the global quality management system for the largest human data science company in the world. The QA function is responsible for driving compliance in a highly regulated industry through audits, functional support, issue & CAPA management, regulatory consultancy, management of data analytics and customer relationship interactions. These services ensure our clinical research activities are of the highest quality. We proactively support our business partners and help to drive innovation. Continuous improvement is a core capability and we value strategic thinking, creativity, and operational excellence. We seek highly motivated people who truly want to make a difference in the life sciences industry and are looking for opportunities to impact the business and be part of the solution. At IQVIA, we support our colleagues with a focus on succession planning, career progression and continuous learning.
A Sr. Auditor is responsible for providing support to project teams in the promotion of compliance with regulations, guidelines, and operating procedures. Lead and support effective management of significant quality issues (QIs) and audit and inspection responses including the assessment and review of investigations, appropriate root cause analysis and corrective and preventative actions. Provide consultation in interpretation of regulations, guidelines, policies, and procedures.
**Summary of Responsibilities:**
+ Evaluate audit and inspection findings and review responses for project teams, management, and customers
+ Provide consultation to the project team on the interpretation of audit observations and formulation of corrective action plans
+ Review investigations, Root Cause Analysis (RCA), Corrective and Preventative Actions (CAPA) and Effectiveness Check (EC) plans and track until closure for quality events arising from Quality Issues, Audits and Inspections
+ Guide CAPA owners in all required elements and best practices assuring CAPAs and responses are compliant with IQVIA and / or Sponsor requirements, GCP guidelines and relevant regulations
+ Manage and maintain quality events updates in the electronic quality management system (eQMS) and provide support in relation to the audit lifecycle
+ Ensure timely resolution of quality issues and completion of audit and inspection responses and any resulting follow up, within the agreed timelines
+ Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
+ Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures
+ Present educational programs and provide guidance to operational staff
+ Lead, collaborate and support QA initiatives/projects for quality and process improvements
+ Assist in training new Quality Assurance staff
**Required Knowledge, Skills and abilities** :
+ Thorough understanding of GCP, GxP, and other relevant requirements of regulatory agencies (FDA, EMA, PMDA) and demonstrated experience interpreting and applying relevant regulations, laws and guidelines.
+ Possess strong organizational skills for prioritizing workload and responsibilities
+ Strong communication and interpersonal skills including the ability to liaise successfully with cross-functional teams
+ Excellent problem solving and root cause analysis skills
+ Ability to initiate assigned tasks and work independently
+ Ability to handle multiple projects and work effectively in a fast-paced changing environment
+ Ability to establish and maintain effective working relationships with coworkers, managers and clients.
+ Proficient in Microsoft Office applications (Word, Excel)
**Required Education and Experience:**
+ Bachelor's degree in a scientific or healthcare-related field preferred
+ Demonstrated GCP experience
+ Minimum 5 years of experience in a pharmaceutical, biotech, or other regulated are, of which 3 years are in Quality Assurance.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at [ Link removed ] - Click here to apply to Sr. GCP QA Auditor (Clinical Trial)
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. [ Link removed ] - Click here to apply to Sr. GCP QA Auditor (Clinical Trial)
As the COVID-19 virus continues to evolve, IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. [ Link removed ] - Click here to apply to Sr. GCP QA Auditor (Clinical Trial)
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