Enhance compliance efforts as the Principal Expert at Roche. Leverage your expertise in regulatory filings to drive innovation and ensure safe materials are used in medicine.
In this senior role within Roche's Pharma Technical Operations, you will serve as the global expert for Direct Materials Certification and Filing. Collaborating with various stakeholders, you will lead initiatives that standardize processes across different therapeutic areas while ensuring compliance with stringent regulations.
Key Responsibilities:
• Strategically execute the Certification & Filing framework globally
• Develop innovative compliance strategies for various products
• Influence technology upgrades through stakeholder engagement
• Tackle complex regulatory challenges with data-driven insights
• Provide final approvals for significant compliance documentation
Requirements:
• BS/MS/PhD in Science or related fields; 8 years minimum experience
• Expertise in ICH, ISO, and GMP standards
• Proficient in Six Sigma and Lean principles
• Proven ability to lead in a global matrix setting
• Strong communicator with a collaborative mindset
Lead the charge in ensuring direct materials compliance at Roche with your strategic insight and regulatory acumen.
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