Senior Quality Lead - Remote QA Strategy & Audits

Roche; United States; Híbrido; USD 141 000 - 262 000; Tempo integral

Resumo da oferta

Genentech is seeking an experienced Senior Quality Lead to join the Quality Assurance Programs team in South San Francisco, CA. You will design and deliver quality strategies, lead audits, and mentor colleagues while partnering with stakeholders across Molecules, Devices, and regulatory affairs.

This role emphasizes GCP/GVP proficiency, data-driven decision making, and preparation for regulatory inspections. Onsite preferred with remote option; relocation is not offered.

Qualificações

• Bachelor’s degree or equivalent in scientific or quality field; advanced degree preferred.
• Demonstrated knowledge of clinical/pharmacovigilance/regulatory requirements.
• Experience leading multiple complex audit types in GCP areas.
• Ability to host/regulatory authority inspections or support them.

Responsabilidades

• Designs and delivers Quality Strategies and conclusions for Molecules by applying risk-based CtQ framework.
• Define and Lead Audits and develop methodology; perform audits and report outcomes.
• Independently manage complex quality issues and drive CAPA.
• Draw conclusions on Quality Positions and present observations to stakeholders.
• Contribute to PDQ goals and initiatives and support inspections by health authorities.
• Mentor and develop other Quality Leads and lead cross-functional projects.

Conhecimentos

GCP knowledge

GVP knowledge

Audit leadership

Data analytics

Regulatory inspections

Cross-functional leadership

Mentoring

Formação académica

Bachelor's degree in science/quality

Advanced degree preferred

Ferramentas

Excel

Data visualization tools

Descrição da oferta de emprego

Genentech is seeking an experienced Senior Quality Lead to join the Quality Assurance Programs team in South San Francisco, CA. You will design and deliver quality strategies, lead audits, and mentor colleagues while partnering with stakeholders across Molecules, Devices, and regulatory affairs.

This role emphasizes GCP/GVP proficiency, data-driven decision making, and preparation for regulatory inspections. Onsite preferred with remote option; relocation is not offered.