WHO WE ARE

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

WHAT YOU WILL DO

• Identifies and implements improvements within QMS and QMD processes, collaborating on solution-focused activities.
• Develops strategies to engage employees and ensure visibility, access, and clarity of quality procedures.
• Champions change management, particularly related to QMDs, processes, and technology.
• Conducts root cause analysis investigations to address internal and external audit findings related to QMD and QMS.
• Assists in overseeing QMD management processes as a deputy on the QMD/QMS-Governance Committee, ensuring compliance with GxP regulations and defining KQIs and QTLs.
• Collaborates with process owners to design workflows and develop clear, concise QMDs and related GxP documents.
• Conducts initial QMD collaborative reviews and supports formal QMD quality control activities as needed.
• Assists in creating process maps and transforming them into QMDs or supporting materials.
• Provides training on process mapping, workflow design, procedure writing, and content review to process owners, subject matter experts, and collaborative reviewers.
• Supports training of functional training coordinators on QMD/QMS assignments.
• Assists in designing training and communications related to specific training content and supervision.

WHAT YOU WILL BRING TO THE ROLE

• Proficient in developing quality management documents, designing process workflows and accompanying job aids in collaboration with subject matter experts
• Experience in project management of complex cross-functional projects, identifying process connections and gaps
• Proficient in developing workflows in electronic Document Management Systems (eDMS) preferred
• Experience developing and tracking key quality metrics to identify areas for improvement
• Demonstrated success managing quality system elements, such as noncompliance management and document change control
• High degree of initiative, decision making skills and responsibility, enabling the incumbent to perform effectively with minimal supervision
• Ability to effectively prioritize and manage multiple projects and tasks and to assist subject matter experts in meeting timelines
• Communicates in an open, clear, complete, timely and consistent manner and express ideas in written and oral context
• Exhibits a flexible, regulatory-focused approach to problem solving and applies risk-based decisions
• Is an adept negotiator, assisting process owners to reach cross-functional consensus on content