Global Direct Materials Regulatory Expert

Genentech; Oceanside (CA); On-site; USD 114,700 - 212,900; Full time

Job summary

Genentech seeks a Principal Expert to act as the technical authority for Direct Materials Certification and Filing. You will provide global oversight, develop enterprise strategies, and ensure regulatory compliance across biologics, synthetic molecules, and related areas.

You will lead modernization efforts in materials management, drive quality and compliance, and collaborate with External Quality, Procurement, Regulatory, and Manufacturing to align on standards and processes.

Qualifications

• BS/MS/PhD in Science, Engineering or Management with regulatory filings experience.
• Strategic leadership with ability to coach in a matrix organization.
• Expert knowledge of ICH/ISO standards and GMP operations.
• Experience in regulatory filings and material specifications.

Responsibilities

• Global governance: design and execution of Certification & Filing processes across biologics, synthetic molecules, and PTC areas.
• Develop enterprise Direct Materials Certification & Filing strategies and ensure global compliance.
• Influence stakeholders across PTD, PTM, PTT, PTC and PTQ to enable program success.
• Apply data-driven analysis to high-risk regulatory challenges and ensure inspection readiness.

Education

BS/MS/PhD in Science/Engineering/Management

Strategic leadership

Advanced knowledge of international standards (ICH, ISO)

Regulatory filings experience

Tools

Six Sigma

Lean Principles

FMEA

Statistical methods

Job description

Genentech seeks a Principal Expert to act as the technical authority for Direct Materials Certification and Filing. You will provide global oversight, develop enterprise strategies, and ensure regulatory compliance across biologics, synthetic molecules, and related areas.

You will lead modernization efforts in materials management, drive quality and compliance, and collaborate with External Quality, Procurement, Regulatory, and Manufacturing to align on standards and processes.