Operational Quality Manager (Project Services)

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

Job Overview

This is a global role to provide guidance and support to coordination and execution of quality goals at functional level, according to trends and best practices within the Project Services organization.  Partnering with the Project Managers, to craft audit responses, Quality Issues investigations, CAPA plans, process and system changes as necessary in the execution and fulfillment of duties.

Essential functions

• The OQM is responsible for the oversight and management of functional area quality incidents and CAPAs as follows:
• Subject Matter expert in writing investigations and performing Root Cause Analysis for the functional area. Work with functional groups to obtain/provide investigation details.
• Coordinate CAPAs to address root causes and effective checks of preventive actions.
• Evaluate and monitor status of ongoing investigation and CAPA/timelines and effectiveness of actions.
• Evaluate and monitor quality metrics for department processes, internal and external audit findings and responses, trends in quality issues and audit findings. Report functional area performance.
• Coordinate and conduct meetings (routine, ad-hoc) with responsible personnel to ensure adherence to the defined cycle TATs (e.g., on-time reporting, on-time investigation, on-time CAPA plan, on-time total CAPA). Meetings may include regional functional area quality management committee meetings as well as global functional area quality management committee meetings.
• Write Sponsor communications/letters on incident resolution as needed.
• Provide training to regional/global teams according to CAPAs, as needed. Create QI-process related training materials and provide periodic training to functional personnel to ensure compliance.
• Identify  opportunities for major system and process changes to drive quality process improvements. 

Ideal candidate profile

• At least 4 years of relevant experience in managing complex laboratory projects, as a lead project manager.
• A good understanding of existing processes & SOP framework
• Innovate at will, to develop out-of-the-box solutions
• A strong communicator in English, both spoken & written, as the role will require strong proficiency to write SOP literature.
• Excellent collaboration track record, with an eye for building relationships.

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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.