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Senior QA Auditor

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Primary Location: Durham, North Carolina, United States Full time R1199066

Job description

Summary:

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.

Purpose:

A Sr QA Auditor is responsible for providing support to management in the promotion and assessment of compliance with regulations, guidelines, and operating procedures.  Manage QA oversight of projects, assignments, and training.  Collaborates with Quality counterparts at customers and with internal project teams to proactively promote, support and facilitate proactive quality through the identification and management of risks and implementation of quality improvement activities. Provide consultation in interpretation of regulations, guidelines, policies, and procedures.

Summary of Responsibilities:

  • Plan, schedule, conduct, report and close GCP investigator site 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
  • Plan, schedule, conduct report and close, internal process audits and Phase I clinic and vendor audits.
  • 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
  • Manage Quality Issues
  • Present educational programs and provide guidance to operational staff on compliance procedures
  • Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closures for quality events arising from Quality Issues, Audits, Inspections or during similar QA activities
  • Provide quality assurance consultancy activities and projects for clients within budget and established timelines
  • Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
  • Host audits/inspections, Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections    

Required Knowledge, Skills and abilities:

  • Knowledge and experience working with ICH-GCP guidelines
  • Knowledge of word-processing, spreadsheet, and database applications.
  • Extensive knowledge of pharmaceutical research and development processes and regulatory environment
  • 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.

Required Education and Experience:

  • Experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance. GCP experience. Equivalent combination of education, training and experience.
  •  Minimum 2 years of experience in a pharmaceutical, biotech, or other regulated are, of which 3 years are in Quality Assurance.

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At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

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