Global Quality Lead, Pharma Development

Genentech; United States; On-site; USD 111,000 - 206,000; Full time

Job summary

Genentech seeks a Quality Lead in PDQ to shape the future of quality management across development and pre/post-approval products. You will implement robust QA strategies, lead audits, and partner with global stakeholders to ensure FDA, EU, and ICH compliance while enabling safe, efficient patient access.

In a global, agile matrix environment you’ll drive risk-based decisions using the CtQ framework, manage inspections preparation, and contribute to continuous improvement of PDQ processes with

Qualifications

• Education: Bachelor’s degree in a scientific or quality-related field or equivalent.
• Industry Experience: pharma/biotech/medical device with end-to-end product ops.
• GxP Knowledge: familiarity with global GxP regulations (GCP, GVP, IVD/MD).
• Data & Digital Literacy: strong audit management and data reporting skills.
• Critical Thinking: proven problem-solving and project management abilities.

Responsibilities

• Drive Quality Strategies: execute risk-based QA strategies and conclusions in GVP/GCP using CtQ.
• Lead Global Audits: plan, perform, and group issues into trends for regulatory compliance.
• Partner with Stakeholders: present observations and risks clearly to business partners.
• Support Inspections: assist in regulatory inspection preparation and management.
• Advance PDQ Processes: contribute to PDQ goals and continuous improvement.
• Maintain GxP Expertise: stay current on FDA, EU, ICH guidance across GxP.

Skills

Quality Assurance

GxP regulations

Data analytics

Stakeholder communication

Project management

Critical thinking

Education

Bachelor’s degree in science/quality field

Job description

Genentech seeks a Quality Lead in PDQ to shape the future of quality management across development and pre/post-approval products. You will implement robust QA strategies, lead audits, and partner with global stakeholders to ensure FDA, EU, and ICH compliance while enabling safe, efficient patient access.

In a global, agile matrix environment you’ll drive risk-based decisions using the CtQ framework, manage inspections preparation, and contribute to continuous improvement of PDQ processes with