Global Direct Materials Certification & Filing Expert

F. Hoffmann-La Roche AG; Mississauga; On-site; CAD 115,000 - 151,000; Full time

Job summary

Hoffmann-La Roche Ltd. seeks a PT Operations Expert to lead Direct Materials Certification and Filing strategies, ensuring compliance with Health Authority requirements and efficient product lifecycle support.

You will collaborate across External Quality, Procurement, Planning, QC, QA, Manufacturing, Development, and Regulatory. Requirements include a BS/MS/PhD in Science, Engineering or Management and 5+ years in pharma or medical device regulatory filings, quality systems, and GMP operations.

Qualifications

• Significant experience in regulatory filings and material specifications is an advantage.
• Proven ability to lead cross-functional teams in global settings.
• Knowledge of ICH guidelines, ISO standards and GMP operations is preferred.

Responsibilities

• Design and robustly execute the Certification and Filings business process.
• Oversee content for biologics and synthetic molecules, including health authority filings.
• Maintain global inspection readiness and coordinate with QA, Regulatory, and Manufacturing.

Skills

Project management

Regulatory filings

Quality systems

Pharma GMP operations

Health Authority regulations

Six Sigma

Lean

Cross-functional collaboration

Education

BS/MS/PhD in Science, Engineering or Management

Job description

Hoffmann-La Roche Ltd. seeks a PT Operations Expert to lead Direct Materials Certification and Filing strategies, ensuring compliance with Health Authority requirements and efficient product lifecycle support.

You will collaborate across External Quality, Procurement, Planning, QC, QA, Manufacturing, Development, and Regulatory. Requirements include a BS/MS/PhD in Science, Engineering or Management and 5+ years in pharma or medical device regulatory filings, quality systems, and GMP operations.