Senior Quality Lead - GCP, Audits & Regulatory Strategy

F. Hoffmann-La Roche AG; Oregon; Hybrid; USD 141,000 - 262,000; Full time

Benefits offered by this job

Discretionary annual bonus

Remote option in some cases

Job summary

Genentech is seeking a Senior Quality Lead to join the Quality Assurance Programs team. You will develop and deliver QA strategies, lead audits across GCP/CSV/device domains, and mentor Quality Leads in a global, matrixed organization.

Strong regulatory and data analytics skills are required. The role focuses on risk-based quality assurance, inspections support, and collaboration with stakeholders to ensure compliance across Molecules and Drugs.

Qualifications

• Bachelor's degree or equivalent in scientific or quality-related field.
• Demonstrated knowledge of clinical/pharmacovigilance/drug safety and regulatory requirements.
• Project management experience with leadership, mentoring and coaching; ability to organize and execute tasks.
• High degree of experience leading multiple complex audit types in multiple GCP areas.

Responsibilities

• Designs and delivers Quality Strategies and conclusions for assigned Molecules by applying risk-based CtQ framework.
• Define and Lead Audits: define audits and lead development of methodology; perform and lead audits and report outcomes.
• Issue Management: independently manage complex quality issues and escalate significant issues to PDQ management.
• Quality Conclusion and Stakeholder Communication: draw conclusions on Quality Positions and present observations to stakeholders and regulatory affairs.
• PDQ Goals and Initiatives: contribute to PDQ goals and development of PDQ processes.
• Health Authority Inspections: lead and support regulatory authority inspections.

Skills

GCP knowledge

Auditing

Quality Assurance

Data analytics

Stakeholder communication

Education

Bachelor's degree in science or quality

Advanced degree preferred

Job description

Genentech is seeking a Senior Quality Lead to join the Quality Assurance Programs team. You will develop and deliver QA strategies, lead audits across GCP/CSV/device domains, and mentor Quality Leads in a global, matrixed organization.

Strong regulatory and data analytics skills are required. The role focuses on risk-based quality assurance, inspections support, and collaboration with stakeholders to ensure compliance across Molecules and Drugs.