Senior Project Quality Assurance Lead - Worldwide Clinical Trials

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!

Job Description

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

Collaborate with project team members to ensure compliance with study protocols and regulations.

Acts as GCP Subject Matter Expert (SME) providing GCP consultancy to project teams for assigned projects.

Manages and facilitates investigation and root cause analysis for Quality Issues (QIs) including development of Corrective and Preventive Action (CAPA) Plans for assigned projects.

Participates in risk management activities.

Proactive identification of risks to ensure mitigations and controls are in place.

Performs quality assurance review and trending activities for assigned projects.

Provides Clinical Investigator Site inspection and audit support as required.

Provides GCP consultancy and reviews QMD deviations for project teams.

Collaborate with Therapeutic Area Quality Leads within the QMO team and support with managing the QA-to-QA relationship with Sponsor QA counterparts and quality metrics.

Assist with Sponsor audits and regulatory inspections as assigned.

What you will bring to the role

Professional, concise, clear, and consistent communication and approach for internal and external customers.

Serves as a positive QA ambassador during all daily activities and cus