Senior Global Clinical Quality & Policy Leader

F. Hoffmann-La Roche AG; South San Francisco (CA); Hybride; USD 175 000 - 325 000; Plein temps

Résumé du poste

Genentech, part of the Roche group, seeks a Principal Clinical Quality Compliance and Policy Lead to champion a proactive quality culture across Early Clinical Development (ECD) study teams. You will translate global regulatory requirements into pragmatic compliance strategies to advance our early-stage pipeline.

This role drives cross-functional alignment, oversees QMS activities, and leads inspection readiness initiatives, with a strong emphasis on governance, risk mitigation, and strategic

Qualifications

• Bachelor’s degree in life sciences or related healthcare discipline.
• 7–12 years of progressive pharma drug development experience (6–8 years with a Master’s; 5–7 years with a PhD/JD/MD).
• 8+ years in a GCP-related discipline or clinical quality assurance role with expert knowledge of GCP/ICH guidelines and global health authority regulations.

Responsabilités

• Provide strategic quality direction and GCP compliance across Early Clinical Development (ECD) study programs.
• Lead global initiatives, working groups, and policy development as a key decision-maker.
• Oversee Quality Management System (QMS) activities, including deviation management and CAPA evaluations.
• Lead Health Authority inspection readiness initiatives and regulatory responses.

Connaissances

Strategic leadership

Matrix leadership

Influential communicator

Regulatory compliance

Formation

Bachelor’s degree in life sciences or related discipline

Description du poste

Genentech, part of the Roche group, seeks a Principal Clinical Quality Compliance and Policy Lead to champion a proactive quality culture across Early Clinical Development (ECD) study teams. You will translate global regulatory requirements into pragmatic compliance strategies to advance our early-stage pipeline.

This role drives cross-functional alignment, oversees QMS activities, and leads inspection readiness initiatives, with a strong emphasis on governance, risk mitigation, and strategic