Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality.Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.

Our talented team of 3,500+ professionals spans 60+ countries.We are united in cause with our customers to improve the lives of patients through new and innovative therapies.

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 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)
• Serves as a positive ambassador of the QA organization with internal and external customers.
• Participates in the crafting of the QA organizational goals and objectives for the Internal Audit Program and the Contracted Audit Program
• Responsible for the planning and optimizing resources (budgets, staff and technologies) for the advancement of the Late Phase Internal Audit Plan and the Worldwide Contracted Audit Program.
• Responsible for overseeing direct reports and managing auditor assignments, performance, and continuous training.
• Ensures quality deliverables, on time, and in compliance Worldwide processes for the Late Phase Internal Audit Program and the Worldwide Contract Audit Program
• Oversees, monitors QA audits to ensure timely completion of applicable CAPAs to prevent reoccurrence and to drive process improvements.

What you will bring to the role

• Demonstrate ability to define KQIs and KPIs, delivering quality metrics for the Internal Audit Program and the Contract Auditing Program
• Demonstrates excellent organizational leadership competencies, inclusive of scheduling and leading team meetings that are effective, efficient, and documented.
• Demonstrates excellent decision-making skills. Acts with authority to drive performance and accountability.
• Demonstrates excellent skillset for influencing, being resourceful, managing conflict and negotiating.
• Demonstrates ability to work collaboratively with cross functional stakeholders to drive process improvements based on Quality Indicators
• Excellent interpersonal, communication, and presentation skills.

Your experience

• Bachelor’s degree or four-year equivalent with concentration in scientific or allied health field and minimum of 10 years of relevant GCP, GcLP, GVP experience or a Master’s degree in a scientific or allied health field and minimum of 7 years of relevant audit experience (e,g, GCP, GcLP, GVP )
• Must have 3 years of demonstrated project management experience within last 10 years.
• Minimum of 3 years of managerial experience
• Experience in conducting auditor training sessions.
• Excellent working knowledge of ICH Guidelines, FDA regulations, European Directives, UK Statutory Instruments, and AIFA CRO Decree
• Recent experience in last 3 years for conducting QA Audits, specifically GCP for each type (i.e. Clinical Investigator Audits, Vendor Audits, Internal Process Audits, For-cause Audits, TMF Audits, PV)