Senior Project Quality Assurance Lead - Europe - Remote

Overview

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.

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!

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.

• Lad QA activities and deliverables across multiple complex and global studies and programs as assigned.
• Collaborates 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 and programs
• Provides GCP consultancy and reviews QMD deviations for assigned projects and programs.
• Collaborates with the Therapeutic Area Quality Lead(s) within the Quality Management Oversight (QMO) team and supports with managing the QA-to-QA relationship with Sponsor QA counterparts and quality metrics.
• Assist with Sponsor audits and regulatory inspections as assigned.

• Professional, concise, clear, and consistent communication and approach for internal and external customers.
• Serves as a positive QA ambassador during all daily activities and customer interactions
• Competent to manage projects/teams of significant scope and complexity with enthusiasm, prioritizing workload with attention to detail while meeting all deliverables and timelines.
• Works with a sense of urgency and recognizes and delivers on time sensitive deliverables.
• Strong influencing and negotiation skills.

• Bachelor’s degree or equivalent with concentration in biological, physical, health, pharmacy or other related science and 7+ years of relevant GCP experience
• OR 5+ years of relevant GCP experience with a M.S. or equivalent in a scientific or allied health field preferably within a Clinical Research Organization (CRO) or pharmaceutical company setting.
• Excellent working knowledge of Quality Management Systems, ICH Guidelines, FDA Code of Federal regulations, European Directives and Regulations, and UK Statutory Instruments relevant to GCP.
• GxP (e.g., GLP, GMP, GPVP, GPP) knowledge in addition to advanced GCP knowledge preferred.
• Domestic and international travel may be required (not exceeding 15%).

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

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit  or…