Clinical Quality Assurance - Program Lead (Associate Director)

Responsibilities

• Provide Clinical Quality Assurance leadership for assigned programmes and trials, drawing on a clear view of how departments connect and what the business needs to achieve.
• Drive the quality strategy within the Global Clinical Team and Clinical Trial Team you support, so that quality is built into how each trial is planned and run.
• Monitor delivery of the annual Quality Plan for assigned programmes and studies, so that agreed quality actions stay on track.
• Oversee the proactive quality risk management process, including quality risk assessments and submission and inspection readiness activities, and confirm that Clinical Trial Processes remain in control.
• Work with Country Development Quality, Development Units and members of the Global Clinical Team and Clinical Trial Team to detect risks early and make sure they are resolved.
• Support core governance for quality incident management, including critical and major deviations in your programmes, and escalate promptly when needed.
• Answer day-to-day Good Clinical Practice questions that arise from clinical trial deliverables, giving teams clear and practical guidance.
• Partner with Country Development Quality Assurance and External Service Provider Quality Assurance to lead initiatives on internal monitoring and on quality oversight of outsourced activities.
• Lead inspection preparation and facilitation with other Quality Assurance groups in Research and Development Quality, and support audit and inspection follow-up, including preparing Corrective and Preventive Actions, then use audit and inspection outcomes and trends to improve how trials are conducted.
• Act as the Quality Assurance point of contact for defined trials, attend their meetings so quality shapes decisions, and take an active part in continuous improvement work streams so that identified weaknesses are addressed and the improvements last.

Essential for the role

• Bachelor's degree in a life science or healthcare field.
• Extensive experience in regulated activities such as Good Clinical Practice or Pharmacovigilance, in clinical development and/or in Quality Assurance roles.
• Strong understanding of how clinical trials are run.
• Broad understanding of global Health Authority expectations in clinical development, and a deep understanding of the science of product development.
• Strong skills in Good Clinical Practice, clinical quality and/or clinical development.
• Experience managing projects.
• Ability to work independently in a global, matrix environment.
• Skills in stakeholder management, risk management, regulatory compliance, leadership and problem solving.

Desirable for the role

• Advanced degree in life sciences or healthcare, such as a PhD, Doctor of Medicine, Doctor of Pharmacy or Master's degree.
• Experience in audit and inspection management, including preparing Corrective and Preventive Actions and leading teams through Health Authority inspections.