Senior / QA Project Lead - NA / Europe - Remote

Quality Assurance Specialist

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.

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 :

Your background :

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.