Drive global strategies for Direct Materials Certification at Roche. Leverage your regulatory expertise to navigate complex challenges in pharmaceutical compliance and ensure timely solutions.

Roche is seeking a Principal Expert for its Pharma Technical Operations group. This senior role requires an in-depth understanding of regulatory filings and direct materials certification across various therapeutic areas including Biologics and Gene Therapy. Your leadership will influence stakeholders and streamline processes to maintain compliance and operational excellence.

Key Responsibilities:
• Design global Certification & Filing processes for diverse therapy areas
• Develop Direct Materials strategies aligning with regulatory compliance




• Influence stakeholders for successful technology implementation
• Solve complex regulatory challenges using data-driven approaches
• Review and approve compliance documents with authority

Requirements:
• BS/MS/PhD in Science, Engineering or Management
• 8+ years in pharmaceuticals or medical device sectors
• Expertise in international standards and GMP operations
• Advanced knowledge of Lean and Six Sigma tools
• Exceptional communication and team leadership skills

Utilize your strategic vision and regulatory expertise to lead Direct Materials compliance efforts at Roche.
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📌 Principal Expert in Direct Materials Compliance (Ontario)
🏢 Roche
📍 Ontario