Senior Clinical QA Lead - Global GxP & Audits

Summit Therapeutics; United States; A distancia; USD 158.000 - 185.000; Jornada completa

Descripción de la vacante

Summit Therapeutics Inc. in the United States seeks a Quality Assurance professional to ensure GCP/GLP compliance across global clinical programs.

You will partner with Regulatory Affairs, QA, R&D and cross-functional teams to provide quality guidance and drive compliance with applicable guidelines and standards. The role emphasizes audit management, CAPA oversight, vigilance for HA inspections, and continuous process improvement, with travel up to 20%.

Formación

• Bachelor's degree in Life Sciences, Pharmacy or Nursing; Master's preferred.
• 5+ years QA or clinical operations experience in regulated activities.
• Broad understanding of global Health Authority expectations for trials.
• GCP/GLP knowledge (FDA/EU) and pharmacovigilance familiarity.
• Mandarin language desirable; ability to travel up to 20%.

Responsabilidades

• Provide QA support to Summit Clinical and pre-clinical programs with cross-functional teams.
• Manage audits including clinical sites and vendor qualification.
• Oversee CAPAs, corrective actions and preventive actions.
• Assist in inspection readiness for FDA/EU HA pre-approval and sponsor inspections.
• Support investigations and escalate critical incidents as needed.
• Drive continuous process improvements with QA and stakeholders.

Conocimientos

Quality Assurance

Regulatory knowledge

Communication skills

Attention to detail

Multi-tasking

Travel willingness

Mandarin (desirable)

Educación

Bachelor's degree in Life Sciences/Pharmacy/Nursing

Master's degree preferred

Descripción del empleo

Summit Therapeutics Inc. in the United States seeks a Quality Assurance professional to ensure GCP/GLP compliance across global clinical programs.

You will partner with Regulatory Affairs, QA, R&D and cross-functional teams to provide quality guidance and drive compliance with applicable guidelines and standards. The role emphasizes audit management, CAPA oversight, vigilance for HA inspections, and continuous process improvement, with travel up to 20%.