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 almost 2,500 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 the Director, Quality Management GCP (Therapeutic Area Quality Lead) does at Worldwide

The Therapeutic Area Quality Lead (TAQL) is a highly visible role within the Quality Management Oversight department responsible for GCP focused QA activities for clinical trials in an assigned Therapeutic Area.

What you will do

• Act as GCP Subject Matter Expert, providing GCP consultancy to project teams within the assigned Therapeutic Area and for assigned functional area(s).
• Oversight of the management of quality issue investigations, root cause analysis and corrective / preventive actions.
• Establish and maintain QA-to-QA relationships with Sponsor QA counterparts within the Therapeutic Area, including the development and management of Quality Agreements and quality metrics.
• Represent Quality Management Oversight department in Sponsor audits.

What you will bring to the role

• GCP focused expertise and demonstrated experience to provide oversight of the management of issues supporting projects/teams with enthusiasm and keen attention to detail to meet deliverables and timelines.
• Professional, concise, clear, and consistent communication and approach for internal and external customers.
• Clinical trial international or local regulation and guidance expertise.

Your experience

• Bachelor’s degree or equivalent with concentration in biological, physical, health, pharmacy or other related science and 10+ years of relevant GCP experience or 7+ years of relevant GCP with a M.S. or equivalent in a scientific or allied health field preferably within a Clinical Research Organization (CRO) or pharmaceutical company setting.
• Excellent working knowledge of, ICH Guidelines, FDA Code of Federal regulations, European Directives and Regulations, and UK Statutory Instruments relevant to GCP.
• Excellent understanding of drug development processes.
• GLP, GMP, GPVP and / or GPP knowledge in addition to strong GCP knowledge preferred but not required.
• Experience with Microsoft based applications, including proficiency in Excel, Word, SharePoint, and PowerPoint.

Why Worldwide



At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it - because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!