Purpose:

The Director, Quality Assurance is responsible for serving as a strategic partner to external customers and internal project teams to drive GCP and PV quality, ensuring that that projects and deliverables are in compliance with regulatory requirements and industry best practices  This is a highly visible and important position within QA and requires both strategic vision and personal tactical execution.

Summary of Responsibilities

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. Provides actionable insights from quality and operational data analysis and proactively working with the customer and the account team to develop action plans to drive continuous improvement. Analyzes trends in quality issue reporting and timeliness to ensure adherence to quality issue management requirements across project teams Supports the management and resolution of significant issues relating to quality; In collaboration with Quality Management, ensures projects are inspection ready starting at the design stage. Drives inspection readiness activities for the customer, including contributing to mock inspections by/of the customer Contributes to the development of the global risk-based internal audit plan. Advises customer Quality counterparts on the strategy for regulatory inspections and collaborates in the preparation for and management of inspections at customer offices and, as necessary, at investigator sites. Prepares for and actively participates in relevant Governance/partnership level meetings e.g. Quality Councils/ Joint Operations Committee (JOC) or equivalent meetings with customer Quality counterparts. Interfaces with senior management to discuss quality and compliance issues Interfaces with business development and operations to identify business opportunities Hosts and/or supports customer audits and ensures appropriate and sustainable action plans are developed and implemented.

Required Skills:

• 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.
• Strong negotiation and influencing skills; demonstrated ability to work constructively and effectively at all levels across functions as well as with external customers
• Superb and polished ability to consistently present information in a clear, compelling, and understandable format, tailoring presentations to the context and audience. 
• Demonstrable experience and ability to utilize analytics to make data-driven decisions and assess impact of interventions
• Self-motivated and able to work with limited supervision

Required Education and Experience:

• Bachelors degree in a scientific or healthcare-related field
• Demonstrated experience leading and successfully delivering on high-profile quality initiatives with senior executive leadership visibility.
• Minimum 5 years of experience in experience in clinical quality in a pharmaceutical, biotech, or other regulated industry.

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