Auditor, Quality Oversight Vendors and Digital Data - US/Canada - Remote

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 

What you will do

• Serves as a positive ambassador of the Quality organization with internal and external customers.

• Performs Quality audits for Vendors, Internal Process/Computer Systems and other audits, as assigned.

• Ensures quality deliverables, on time, and in compliance with regulations and Worldwide processes, as assigned.

• Support the investigation and resolution of vendor related quality issues.

• Quality Assurance review of computer system validation documentation.

• Participates in the driving continuous process improvements.

• Ensures data and record management in accordance with the QMS.

• Communicates relevant regulatory intelligence that has impact on the QMS to the Quality team, if identified.

What you will bring to the role 

• Ability to work remotely with minimal supervision and guidance.

• Demonstrates good organizational skills and critical decision-making.

• Demonstrate good decision making and project management skills.

• Effective communicator that is concise, clear, and consistent to external and internal customers both verbally and in writing.

• Demonstrated initiative and resourcefulness while working with a sense of urgency.

• Demonstrated ability to prioritize work with some supervision.

Your experience

• Bachelor’s Degree with concentration in nursing, biological, physical, health, pharmacy or other related in a scientific or allied health field and least 2 years of Quality Assurance audit experience.

• Good Understanding of the principles for a GCP Quality Management System.

• Working knowledge of the drug development lifecycle and Good Clinical Practice.

• Working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments.

• Domestic and international travel required (approximately up to 50%).

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.