Clinical Quality Assurance – Program Lead

4 weeks ago

Dublin, Dublin City, Ireland Novartis Ireland Full time
Overview

Clinical Quality Assurance – Program Lead. Location: London, UK, Dublin, Republic of Ireland or Barcelona, Spain. Hybrid working. Associate Director level within Clinical Quality Assurance, providing quality oversight for the end-to-end clinical process for the clinical trials under responsibility to ensure compliance with Health Authorities requirements, internal standards and patient safety, rights and well-being.

Responsibilities
  • Provide QA leadership to the business strategy for assigned programs/trials, ensuring awareness of interdepartmental relationships and business priorities.
  • Drive implementation of the quality strategy within Global Clinical Team (GCT) / Clinical Trial Team (CTT).
  • Regularly monitor the implementation of the annual Quality Plan for the assigned programs/studies.
  • Ensure proactive quality risk management oversight, including quality risk assessments, submission/inspection readiness, and control of Clinical Trial Processes (CTP).
  • Provide robust quality oversight across clinical development: support collaboration with key stakeholders to detect and remediate risks; contribute to governance for quality incident management and timely escalation; provide GCP guidance on day-to-day trial deliverables; collaborate with Country Development QA and External Service Providers QA to drive monitoring and outsourced activity oversight; support inspections preparation and facilitation with RDQ QA groups; support audits/inspections follow-up and CAPA activities.
  • Leverage audit/inspection outcomes and trends to drive continuous improvement in clinical trials conduct.
  • Participate in continuous improvement initiatives and ensure weaknesses are addressed for sustainability.
  • Act as QA point of contact for defined trials and participate in meetings to ensure quality is embedded in decision making.
Essential Requirements
  • Bachelor's degree in life science or healthcare field required; advanced degree (PhD/MD/ PharmD/ Masters) preferred.
  • Minimum 7 years involvement in regulated activities (GCP/PV), clinical development and/or QA roles.
  • Broad understanding of global Health Authority expectations in Clinical Development and strong knowledge of product development science.
  • Ability to work independently and in a global/matrix environment.
  • 3+ years' experience in managing projects.
  • Strong skills in GCP, quality and/or clinical development.

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