Direct Materials Regulatory Filings Principal Expert

Genentech•Oceanside, CA

1d•$114,700 - $212,900•Remote

About The Position

The Pharma Technical Operations Global MSAT & Engineering group takes bold steps to modernize technical operations to enable Roche to deliver medicines for patients more quickly, efficiently and reliably. PTT shapes and accelerates technology innovation and product lifecycle management for tomorrow, while standardizing and driving operational excellence in PT today. As the Principal Expert, you will act as the technical authority and global strategist for Direct Materials Certification and Filing. This position provides high-level technical oversight, proactively implementing enterprise-wide solutions for complex problems and ensuring global compliance with the most stringent Health Authority regulations. The Principal Expert drives the modernization of materials across the entire PT network, ensuring a robust and flexible supply chain from a compliance perspective to support Product Health across the product lifecycle.

Requirements

BS/MS/PhD in Science, Engineering or Management with at least 8 years of experience in the pharmaceutical, biopharmaceutical or medical device industry.
Extensive experience in regulatory filings and material specifications is required.
Proven ability to combine strategic clarity with innovative thinking, aligning with matrix leadership model and coaching capabilities.
Expert-level knowledge of international standards (ICH, ISO), Pharma GMP operations, and Health Authority regulations.
Advanced knowledge of Operational Excellence tools e.g., statistical methods, FMEA, Six Sigma, Lean Principles.
Proven experience working in and leading high-impact teams in a global matrix setting.
Exceptional ability to build connections, influence business needs, and foster a collaborative environment across the enterprise.
Committed to creating an inclusive environment where team members feel safe, valued, and empowered to perform their best.

Responsibilities

Accountable and responsible for the global design and strategic execution of Certification & Filing business processes, ensuring standardization across Biologics, Synthetic Molecules and PTC area.
Leads the development of enterprise-level Direct Materials Certification & Filing Strategies, serving as the primary bridge to PTR for global compliance and Health Authority requirements ensuring simplification and alignment of approaches.
Drives modernization and technology innovation by influencing stakeholders (including senior stakeholders) across PTD, PTM, PTT, PTC and PTQ to drive successful program implementation.
Applies data-driven knowledge to the most complex regulatory challenges, particularly in high-risk areas such as virus-risk, BSE/TSE, and biological-derived material compliance.
Serves as the final reviewer and approver for enterprise-wide compliance, technical, and scientific documents, holding legalization signature authority for Roche products.
Maintains a state of global inspection readiness at all times and spearheads the implementation of major compendia changes or responses to Health Authority audits.
Accountable for building high-level collaborations and work relationships between key stakeholders including External Quality, Procurement, PTC, QC, QA, Manufacturing, and Regulatory.