QA Manager (GCP - PV Customer Audits)

Contenido de trabajo

Remote Opportunity

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, hosting customer audit and regulatory inspections, 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 QA Manager for Customer Audits is responsible for hosting customer audits and assisting with regulatory inspections. Managing QA oversight of projects, assignments, and training. Providing consultation in interpretation of regulations, guidelines, policies, and procedures. Providing support to management in the promotion and assessment of compliance with regulations, guidelines, and operating procedures.

Summary of Responsibilities:

• Scheduling, planning, and hosting customer audits.
• Assisting with regulatory facility inspections by serving as a member of the QA Inspection Management Team.
• Maintain customer audit and regulatory inspection toolboxes.
• 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, functional leads and monitors in interpretation of audit observations and formulation of corrective action plans.
• Prepare, review and approve corrective action plans
• Present educational programs and provide guidance to operational staff on compliance procedures.
• Conduct 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.
• Serve as author of Quality Assurance SOPs as assigned.
• Lead Projects.
• Train new staff, as required.
  

Required Education and Experience:

• Bachelor’s degree in a scientific or healthcare-related field.
• Demonstrated experience scheduling, planning, and hosting customer audits.
• Minimum 3-5 years of experience in experience in clinical quality in a pharmaceutical, biotech, Contract Research Organization or other regulated industry.
  

Required Knowledge, Skills and Abilities:

• Practical experience in scheduling, planning, and hosting customer audits.
• Thorough understanding of GCP, PV, and other relevant quality compliance requirements of major regulatory agencies (FDA, EMA, PMDA) and demonstrated experience interpreting and applying relevant regulations, laws and guidance.
• Practical experience applying proactive quality approaches for clinical trials.
• Preferred experience in Real Word Data / Real World Evidence, Computer System Validation and hosting regulatory inspections.
• Preferred experience in GCP, PV and other GxP auditing.
• Tech savvy.
  

Travel:

• Up to 30-40%
  

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 https://jobs.iqvia.com