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 3,000 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 Quality Assurance Department does at Worldwide

The QA department sets the bar high when it comes to quality. We are committed to exceeding quality standards required by our sponsors, study participants, and regulatory authorities. The QA culture is based on an environment where staff are trained, energized, and empowered to deliver high-quality products to our employees and customers.

What the QA Manager does at Worldwide

The QA Audit Manager will have proven experience and advanced knowledge in appropriate GCP/GxP compliance and other applicable regulations to conduct various types of audits to assess Worldwide Clinical Trials processes and procedures, applicable regulations, and Sponsor SOPs, when necessary. Guides regulatory compliance to internal clients. Provides direction and coordination of project activities related to assigned areas in liaison with QA management. Reports to the Senior Director, QA, and provides guidance, training, and motivation to a group of professional audit specialists.

What you will do
Tasks may include but are not limited to:

• Coordinates and performs audits and completes written reports for each audit assigned.
• Manages and assigns the projects and audit status and provides QA Management with current status upon request.
• Manages the Vendor Audit program and assigns audits as required.
• Monitors regulatory agency and industry compliance standards and trends to assure an appropriate Company compliance program.
• Coordinates and facilitates sponsor audits/regulatory inspections, as assigned.

What you bring to the role

• Sound knowledge of applicable GCP/GxP regulations and requirements as well as WCT policies and procedures.
• Ability to coordinate multiple projects and have the flexibility needed to adjust to changing priorities and unforeseen events.
• Understanding of FDA Part 11 regulations and other international guidelines specifically addressing Computer Systems Electronic Record/Electronic Signature (ERES).
• Ability to interact professionally and to work independently or in teams.

Your experience
Required: Bachelor’s degree preferably in life science and a minimum of five years’ experience in regulatory affairs, auditing, clinical research, monitoring, laboratory, or other relevant area, three (3) of those years must be in quality assurance auditing. Additional experience in a relevant area (clinical setting, laboratory) that is deemed equivalent to education may be applied in lieu of the education requirement.

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.

We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn .