Global Clinical QA Lead – Process Excellence & Compliance

KCR Placement

Reading

Presencial

GBP 85.000 - 110.000

Jornada completa

14 días+

Una candidatura completa en un minuto

Currículum y carta de presentación personalizados, listos para enviar.

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Ventajas ofrecidas por este puesto de trabajo

Annual leave

Health insurance

Retirement planning

Global Employee Assistance Programme (

Life assurance

Descripción de la vacante

ICON Strategic Solutions seeks a GCP QA Senior Project Manager to lead clinical quality programs across global development, ensuring adherence to GCP, ICH, and regulatory requirements. This role focuses on cross-functional process improvements, inspection readiness, and scalable, compliant ways of working, partnering with Clinical Operations, Quality, and Medical Affairs to deliver high-quality trials.

Join a sponsor-dedicated model that values collaboration and continuous improvement in a

Formación

Bachelor's degree in Life Sciences, Clinical Research, Healthcare, or a related field.
7+ years of experience within the biopharmaceutical, biotechnology, CRO, or clinical research industry.
Strong clinical operations, quality, compliance, or process excellence background.
Deep understanding of GCP, ICH guidelines, and global clinical trial conduct.
Demonstrated experience leading cross-functional projects and process improvement initiatives.
Experience authoring and managing SOPs, procedures, work instructions, or other controlled documents.
Excellent project management, communication, facilitation, and stakeholder management skills.
Strong written and verbal English communication skills.

Responsabilidades

Lead development, revision, implementation, and retirement of controlled documents, SOPs, work instructions, and guidance materials.
Drive cross-functional process improvement initiatives that enhance efficiency, compliance, and operational excellence.
Partner with Quality Assurance and Clinical Operations teams to support inspection readiness and regulatory inspection activities.
Lead quality event investigations, root cause analyses, CAPA development, and effectiveness checks.
Manage complex projects involving multiple stakeholders and ensure timely delivery of business objectives.
Facilitate stakeholder alignment and influence process changes across global teams.
Develop and deliver training, onboarding, and learning initiatives to support employee capability and compliance.
Monitor process performance, identify improvement opportunities, and report progress to senior leadership.
Mentor colleagues and serve as a subject matter expert in procedural excellence and clinical quality.