Job Description

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.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

What the Quality Assurance Department does at Worldwide

The Quality Assurance department sets the bar high when it comes to quality. We are committed to exceeding the quality standards required by our sponsors, study participants, and regulatory authorities. Our 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 you will do

• Works with the QA Management to plan, conduct and complete written reports for each audit assigned.

• Monitors the projects and audit status in assigned areas and providesstatus reports.

• Assistswith the management of the Vendor Audit program.

• Facilitates sponsor audits/regulatory inspections.

• Assists with review of audit reports toidentifyimprovements that enhance the quality and clarity of the reports.

• Identifiesareas for process improvement and provides this information to management.

• Assistswith corrective and preventive action plans (CAPAs) to assure follow-up and implementation of corrections for internal and external audits.

• Provides advice and guidance on regulatory requirements and SOPs.

• Assistswith training and mentoring of less experienced auditors.

• Assistswith creating and presenting GCP/GLP and other related training sessions.

• Assists QA Management with review of WCT policies and procedures.

• Oversees the maintenance of records for each audit.

What you will bring to the role

• Sound knowledge of applicableGCPregulations 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.

• Ability to interact professionally and to work independently or in teams.

• Excellent oral and written skills.

Your experience

• Bachelor’s Degree, preferably in Life Science.

• Minimum five (5) 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.

• Additionalexperience in a relevant area (clinical setting, laboratory) that isdeemedequivalent to education may be applied in lieu of the education requirement.

• Willingness to travel

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 Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law