GCP Quality Leader, Early Clinical Development (Hybrid)

Genentech; San Francisco (CA); Hybride; USD 141 000 - 262 000; Plein temps

Résumé du poste

Genentech in South San Francisco is seeking a Quality Partner for Early Clinical Development to champion a proactive, risk-based quality culture and to serve as the primary GCP quality advisor to early-stage study teams and external partners.

You will embed quality by design across cutting-edge programs, resolving compliance challenges before they impact timelines or regulatory integrity. This role drives CAPA and root cause analyses across the organization.

Qualifications

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

Responsabilités

• Develop strategic partnerships across ECD and external partners to improve compliance.
• Provide expert GCP guidance and proactive risk mitigation for trials.
• Lead QMS activities and document management as needed.
• Deliver training to multidisciplinary teams on compliance.
• Lead root cause analyses and CAPA plan development.
• Collaborate with cross-functional teams to align regulatory requirements.

Connaissances

GCP knowledge

Regulatory knowledge

Root cause analysis

CAPA development

Cross-functional collaboration

Stakeholder management

Formation

Bachelor's degree in life science

Advanced degree welcomed (MS/PhD/JD/MD)

Description du poste

Genentech in South San Francisco is seeking a Quality Partner for Early Clinical Development to champion a proactive, risk-based quality culture and to serve as the primary GCP quality advisor to early-stage study teams and external partners.

You will embed quality by design across cutting-edge programs, resolving compliance challenges before they impact timelines or regulatory integrity. This role drives CAPA and root cause analyses across the organization.