Senior GCP Quality Leader for Early Clinical Development

F. Hoffmann-La Roche AG; South San Francisco (CA); Hybrid; USD 141.000 - 262.000; Vollzeit

Benefits dieser Stelle

Discretionary annual bonus

Hybrid schedule

Equal opportunity employer

Zusammenfassung

Genentech, a member of the Roche group, seeks a Quality Partner within Early Clinical Development to champion a proactive, risk-based quality culture that enables innovative science to move safely to patients.

You will serve as the primary GCP quality advisor to trial teams and external partners, embed quality by design, lead CAPA programs, support QMS activities, and guide cross-functional teams through deviation management and inspections.

Qualifikationen

• Bachelor's degree in life science or related field; advanced degree welcomed.
• 5–8 years in pharmaceutical drug development with 6+ years in a GCP/QA discipline.
• Comprehensive knowledge of GCP, ICH guidelines and global regulatory frameworks.

Aufgaben

• Serve as the primary GCP quality advisor to early-stage trial teams and external partners.
• Champion a proactive, risk-based quality culture to move programs safely toward patients.
• Lead CAPA development, root-cause analyses and corrective actions.
• Support QMS activities, controlled documents, and strategic reviews.
• Collaborate cross-functionally to ensure regulatory alignment and data integrity.

Kenntnisse

GCP knowledge

ICH guidelines

CAPA experience

QA in pharma

Cross-functional collab

Analytical skills

Ausbildung

Bachelor’s degree in life science

MS/PhD welcomed

Jobbeschreibung

Genentech, a member of the Roche group, seeks a Quality Partner within Early Clinical Development to champion a proactive, risk-based quality culture that enables innovative science to move safely to patients.

You will serve as the primary GCP quality advisor to trial teams and external partners, embed quality by design, lead CAPA programs, support QMS activities, and guide cross-functional teams through deviation management and inspections.