Senior QA Leader — Clinical Quality & Compliance

Summit Therapeutics; Oregon; Hybrid; USD 158,000 - 185,000; Full time

Job summary

Summit Therapeutics invites a Quality Assurance professional to join our Oregon-based team. The role focuses on providing GCP/GLP and regulatory guidance to clinical study teams, ensuring adherence to global health authority expectations and internal standards.

You will lead audits of clinical sites and vendor qualifications, drive CAPAs, and coordinate inspections with FDA/EU authorities, while partnering with R&D and regulatory affairs to maintain a robust quality program.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy or Nursing required; Master's degree preferred.
• 5+ years QA or Clinical Operations experience in regulated activities.
• Strong knowledge of global health authority expectations (FDA/EU GCP/GLP, ICH) preferred.
• Proficiency in Mandarin Chinese desirable.

Responsibilities

• Provide QA and regulatory guidance to regulatory affairs, QA, and R&D teams.
• Manage audits of clinical sites and vendor qualifications.
• Ensure end-to-end quality management based on Clinical Development Plans.
• Coordinate inspection readiness with FDA/EU authorities and HA.

Skills

Quality Assurance

Clinical Operations

GCP/GLP regulations

Mandarin Chinese

Education

Bachelor's Degree in Life Sciences, Pharmacy or Nursing

Master's Degree or higher

Tools

MS Office

Electronic document management systems

Document review tools

Job description

Summit Therapeutics invites a Quality Assurance professional to join our Oregon-based team. The role focuses on providing GCP/GLP and regulatory guidance to clinical study teams, ensuring adherence to global health authority expectations and internal standards.

You will lead audits of clinical sites and vendor qualifications, drive CAPAs, and coordinate inspections with FDA/EU authorities, while partnering with R&D and regulatory affairs to maintain a robust quality program.