Clinical Quality Assurance – Program Lead

5 days 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.

#J-18808-Ljbffr

  • Clinical Quality Assurance – Program Lead

    2 weeks ago

    Dublin, Dublin City, Ireland Novartis Ireland Full time

    OverviewClinical Quality Assurance – Program Lead at Novartis Ireland. Location: London, UK; Dublin, Rep of Ireland; Barcelona, Spain; Basel, Switzerland. Role type: Hybrid.RoleAs an Associate Director level, Clinical Quality Assurance – Program Lead within Clinical Quality Assurance, you will provide Quality oversight for the end-to-end clinical process...

  • Clinical Quality Assurance Associate

    7 days ago

    Dublin, Dublin City, Ireland Wep Clinical Ltd Full time

    OverviewAre you looking for an exciting and fulfilling new position?Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients.We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference.Be part of a...

  • Clinical Quality Assurance Associate

    2 weeks ago

    Dublin, Dublin City, Ireland WEP Clinical Ltd Full time

    OverviewAre you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of...

  • Senior Clinical Quality Assurance Professional

    5 days ago

    Dublin, Dublin City, Ireland beBeeClinicalQuality Full time €109,250 - €126,800

    Clinical Quality Assurance LeadOur organization seeks a seasoned Clinical Quality Assurance professional to spearhead our quality assurance program. As an Associate Director, you will provide oversight of quality initiatives for clinical trials, ensuring compliance with regulatory requirements and internal standards.Key ResponsibilitiesDevelop and implement...

  • Clinical Quality Assurance Expert

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeQuality Full time €96,000 - €124,000

    Job DescriptionAs a Clinical Quality Assurance Program Lead, you will provide quality oversight for the end-to-end clinical process for assigned programs/trials to ensure compliance with health authorities' requirements and internal standards.You will drive the implementation of quality strategies within global clinical teams, monitor the implementation...

  • Senior Clinical System Lead

    6 days ago

    Dublin, Dublin City, Ireland ICON Clinical Research Ltd Full time

    Senior Clinical System Lead ICON plc is a world-leading healthcare intelligence and clinical research organization.We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.We are currently seeking a Senior Clinical System Lead to join our diverse...

  • Quality Assurance Lead

    3 days ago

    Dublin, Dublin City, Ireland beBeeCompliance Full time €62,000 - €83,000

    Are you a motivated and experienced quality assurance professional seeking new opportunities? We have an exciting job opening for a Senior Specialist Compliance to work on a large-scale project, leveraging cutting-edge technology and developing skills in a fast-paced environment.Job DescriptionThis is an opportunity to work with our team, focusing...

  • Clinical Trial Quality Assurance Specialist

    7 days ago

    Dublin, Dublin City, Ireland beBeeQuality Full time €90,000 - €120,000

    Job OverviewThe Risk-Based Quality Management (RBQM) practice is crucial for driving the adoption of quality standards at trial level. As a key member of our team, you will oversee the implementation and continuous improvement of RBQM practices across assigned trials and programs.This role demonstrates leadership in influencing and improving clinical trial...

  • Senior Clinical Data Science Programmer

    2 weeks ago

    Dublin, Dublin City, Ireland ICON Clinical Research Ltd Full time

    Senior Clinical Data Science Programmer ICON plc is a world-leading healthcare intelligence and clinical research organization.We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.We are currently seeking a Senior Clinical Data Science...

  • R Programming Lead

    3 weeks ago

    Dublin, Dublin City, Ireland Iqvia Full time

    Join a sponsor-dedicated team and contribute to the advancement of in-house study activities over time.As theR Programming Lead, you will provide technical expertise to the Statistical Programming team, ensuring the delivery of high-quality solutions that meet both internal and external requirements.Responsibilities• Develop internal and external R...