Associate Director, QA Audits & Inspections Program - US - 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 

• Champions and adheres to Worldwide’s Quality Management System (QMS). 

• Participates in the crafting of the QA organizational goals and objectives as assigned. 

• Mentors a team of Quality professionals and ensures quality deliverables, on time, and in compliance with regulations and Worldwide processes for all Audit & Inspection activities. 

• Oversees, monitors, and reports for internal and external QA audits to ensure timely completion of applicable CAPAs to prevent reoccurrence and to drive process improvements. 

• Develops and drives continuous process improvements. 

• Participates in the development and review of Quality Management Documents.  

• Assists with tracking and reporting of Key Quality Indications (KQI) and Quality Tolerance Limits (QTL) for the Audit & Inspection Program.  

• Assists with performance of QA audits for Vendors, Internal Process, Clinical Investigator, Document and other audits as assigned. 

• Manages, plans, hosts, reports, documentation and follow up of all Worldwide Sponsor audits. 

• Serves as a core member on the Global Regulatory Inspection Team for all Regulatory Inspections of Worldwide. 

• Provides support to Sponsors Inspections in relation to Worldwide provided services. 

• Serves as a Subject Matter Expert on QA Quality Management processes for Audits and Inspections. 

What you will bring to the role  

• Ability to work with minimal supervision and guidance. 

• Demonstrates excellent organizational leadership competencies, inclusive of scheduling and leading team meetings that are effective, efficient, and documented. 

• Demonstrates excellent decision-making skills. 

• Demonstrates excellent ability to effectively communicate and influence the outcomes of dec