Direct Materials Regulatory Filings Principal Expert

The Pharma Technical Operations Global MSAT & Engineering group is modernizing technical operations to enable Roche to deliver medicines for patients more quickly, efficiently and reliably. The Principal Expert acts as the technical authority and global strategist for Direct Materials Certification & Filing, providing high‑level oversight, implementing enterprise‑wide solutions for complex problems and ensuring global compliance with the most stringent Health Authority regulations.

• Global Governance: Accountable for the global design and strategic execution of Certification & Filing business processes, ensuring standardization across Biologics, Synthetic Molecules and PTC area.
• Strategy Development: 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.
• Stakeholder Influence: Drives modernization and technology innovation by influencing senior stakeholders across PTD, PTM, PTT, PTC and PTQ to implement successful programs.
• Complex Problem Solving: 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.
• Expert Review: Serves as the final reviewer and approver for enterprise‑wide compliance, technical, and scientific documents, holding legalization signature authority for Roche products.
• Compliance Leadership: Maintains a state of global inspection readiness, spearheads implementation of major compendia changes or responses to Health Authority audits.
• Strategic Alignment: Builds high‑level collaborations and work relationships between key stakeholders including External Quality, Procurement, PTC, QC, QA, Manufacturing, and Regulatory.

• Education & Experience: 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.
• Strategic Leadership:
  Proven ability to combine strategic clarity with innovative thinking, matching a matrix leadership model and coaching capabilities.
• Expertise:
  Expert‑level knowledge of international standards (ICH, ISO), Pharma GMP operations and Health Authority regulations.
• Advanced knowledge of Operational Excellence tools such as statistical methods, FMEA, Six Sigma, and Lean Principles.
• E2E Thinking:
  Proven experience working in and leading high‑impact teams in a global matrix setting.
• Outstanding communication and influencing skills, with a track record of fostering a collaborative, inclusive environment.
• Commitment to creating an inclusive environment where team members feel safe, valued, and empowered.

Expected salary range for this position (primary location: California) is $114,700 - $212,900. The actual pay will be determined based on experience, qualifications, geographic location and other job‑related factors permitted by law. A discretionary annual bonus may be available. Relocation benefits are not available for this posting. The position also qualifies for the benefits detailed at the provided link.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to discrimination on the basis of Protected Veteran status, individual's disability status, and consistent with all federal, state, or local laws.

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