Senior Project Quality Assurance Lead - Europe

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.

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:

• Lead QA activities and deliverables across multiple complex and global studies and programs as assigned.
• Collaborate with project team members to ensure compliance with study protocols and regulations.
• Act as GCP Subject Matter Expert (SME) providing GCP consultancy to project teams for assigned projects.
• Manage and facilitate investigation and root cause analysis for Quality Issues (QIs) including development of Corrective and Preventive Action (CAPA) Plans for assigned projects.
• Participate in risk management activities.
• Proactively identify risks to ensure mitigations and controls are in place.
• Perform quality assurance review and trending activities for assigned projects and programs.
• Provide GCP consultancy and review QMD deviations for assigned projects and programs.
• Collaborate with the Therapeutic Area Quality Lead(s) within the Quality Management Oversight (QMO) team and support 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.
• Serve as a positive QA ambassador during all daily activities and customer interactions.
• Competent to manage projects/teams of significant scope and complexity with enthusiasm, prioritising workload with attention to detail while meeting all deliverables and timelines.
• Work with a sense of urgency and recognise and deliver on time sensitive deliverables.
• Strong influencing and negotiation skills.

Your experience:

• 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 (not exceeding 15%).

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritise attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity.