Senior Auditor, Audits and Inspections Program - UK/EU - 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

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

1. Champion and adhere to Worldwide’s Quality Management System (QMS)
2. Serve as a positive ambassador of the QA organization with internal and external customers
3. Develop and execute personal and QA goals and objectives
4. Perform QA audits for Vendors, Internal Processes, Clinical Investigators, Document (Clinical Study reports, Trial Master File, Database) and other audits, as assigned
5. Ensure quality deliverables, on time, and in compliance with regulations and Worldwide processes
6. Oversee, monitor and report on QA audits to ensure timely completion of applicable CAPAs to prevent reoccurrence and to drive process improvements
7. Oversee the maintenance and archiving of records for each audit
8. Participate in driving continuous process improvement
9. Participate in the development and review of AIP Quality Management Documents, as assigned
10. Provide support to Sponsors Audits and Inspections in relation to Worldwide provided services
11. Assist in developing training material and/or deliver training related to audits and inspections
12. Serve as a Subject Matter Expert on QA Quality Management processes for audits
13. Communicate relevant regulatory intelligence that has impact on the QMS to the QA team

What you will bring to the role

1. Possess broad expertise related to understanding the principles and application of quality and regulatory compliance related to GxP activities
2. Excellent working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, and AIFA CRO Decree
3. Possess broad experience related to understanding the principles and application of quality and regulatory compliance related to GxP activities, specifically GCP
4. Excellent experience in conducting QA Audits, specifically GCP for each type (i.e. Clinical Investigator Audits, Vendor Audits, Internal Process Audits, For-cause Audits, Document Audits, etc.)
5. Previous experience in trending and analysis methodologies

Your experience

1. M.S. in a scientific or allied health field and 5+ years of relevant GCP, GcLP, GLP, GVP, and/or GPP experience
2. Excellent understanding of the Drug Development Process
3. Minimum 3 years of Quality Assurance auditing experience
4. IT literate, experienced with Microsoft-based applications, including proficiency in Excel, Word, Trackwise, SharePoint, and PowerPoint
5. Domestic and international travel required

We love knowing that someone is going to have a better life because of the work we do.

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. #J-18808-Ljbffr