Senior Quality Assurance Lead - GCP/CSV Strategy

F. Hoffmann-La Roche AG; South San Francisco (CA); Sur place; USD 141 000 - 262 000; Plein temps

Avantages offerts par ce poste

Discretionary annual bonus

Benefits

Résumé du poste

Genentech, a member of the Roche group, is seeking a Senior Quality Lead in Pharma Development Quality (PDQ) to develop QA strategies and lead audits for post-approval products. Based at South San Francisco, CA, onsite presence is preferred with potential remote options.

The role requires strong GCP knowledge, device/CSV experience preferred, and the ability to influence stakeholders and manage regulatory inspections across global teams.

Qualifications

• Strong knowledge of GCP/GVP regulations and quality systems.
• Experience leading audits and inspections in a GMP/GxP environment.
• Ability to collaborate with global stakeholders.
• Proven leadership and mentoring skills.

Responsabilités

• Designs and delivers QA strategies and conclusions using a risk-based CtQ framework.
• Lead audits and manage methodology, data analytics, and reporting.
• Manage quality issues and drive corrective actions.
• Lead regulatory inspections and communicate findings to stakeholders.
• Mentor Quality Leads and contribute to PDQ processes.
• Collaborate cross-functionally across Molecules, Products, and affiliates.

Connaissances

GCP knowledge

GVP knowledge

Audits

Regulatory inspections

Data analytics

Leadership

Formation

Bachelor's degree or equivalent in science/quality-related field

Advanced degree preferred

Outils

CSV experience

Device experience

Description du poste

Genentech, a member of the Roche group, is seeking a Senior Quality Lead in Pharma Development Quality (PDQ) to develop QA strategies and lead audits for post-approval products. Based at South San Francisco, CA, onsite presence is preferred with potential remote options.

The role requires strong GCP knowledge, device/CSV experience preferred, and the ability to influence stakeholders and manage regulatory inspections across global teams.