Job Information

IQVIA Associate Director of Quality Assurance (Risk Analytics) in Warsaw, Poland

Job Overview:

This position is for an Associate Quality Assurance Director in the Risk Analytics team who will serve as the strategic quality engagement leader focusing on risk analysis projects and tracking for each business function with primary focus on Clinical Operations. The role includes the following activities:

Responsibilities:

• Predominantly supports Clinical Operations globally.

• Provides actionable insights from risk analysis and operational data analysis and working with cross-functional stakeholder 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.

Qualifications

• Bachelor's Degree Mandatory

• 8-10 years experience Quality Assurance experience preferably within a CRO space or related area that includes GCP Quality Assurance experience.

• Knowledge of Excel, spreadsheet, and eQMS platforms (SmartSolve is preferred).

• Strong knowledge of GCP quality standards.

• Considerable knowledge of quality assurance processes and procedures'.

• Strong interpersonal skills and the ability to positively influence and guide others.

• Excellent problem solving and risk/data analysis skills.

• Effective organization, communication, and team orientation skills.

• Possess applicable experience in conducting audits, writing audit reports and analyzing audits.

• Demonstrated ability to lead and manage multiple responsibilities.

• Identify functional constraints and identify solutions.

• Ability to articulate and define departmental needs and processes.

• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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

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