Global Lead for Packaging & Route Validation Standards

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Join Roche, where every voice matters.

As the Global Lead for Packaging & Route Validation Standards
, you are the central authority for ensuring product integrity across the E2E supply chain. You drive competitive advantage by architecting the global technical standards for packaging systems and shipping lane qualifications. This role centralizes critical know-how, ensuring that the global network operates under a unified, "Designed for Distribution" framework. You act as the Global Gatekeeper; while you empower the local network, any deviations or regional modifications to established standards require your strategic review and approval, ensuring absolute regulatory compliance and operational consistency worldwide.

Every day, you strive to lead by example, so that when your team members engage with you, they see a leader who consistently demonstrates our values of Integrity, Courage, and Passion.

What You Do:

• Centralized Standards Ownership: Architect and maintain the Global Master Standards for tertiary packaging qualification (IQ/OQ/PQ) and route validation. You are the definitive source of technical truth for the global network.

• Approval & Variance Management: Serve as the primary authority for the global network. Review and approve/reject requests from individual countries or regions to deviate from global requirements, ensuring that any local adaptations do not compromise global integrity.

• Regulatory Safeguarding
  :
  Ensure that the centralized standards meet or exceed international regulations (ISO 13485, GDP, 21 CFR 820) and are consistently applied across all markets, including the US, EU, and China.

• Knowledge Centralization
  :
  Lead a "Center of Excellence" (CoE) for packaging science, providing the network with validated templates, protocols, and technical guidance to ensure standardization. You are ensuring an efficient management of industry best practices.

Business/Strategy:

• E2E Route Governance: Design the global framework for lane qualifications, utilizing data-loggers and ambient profile mapping to ensure environmental control across complex global routes.

• Strategic Alignment: Build collaborative relationships with R&D, Manufacturing and Quality to ensure centralized packaging standards align with product stability profiles and global regulatory filings.

• Decision-Making & DoA: Manage the Delegation of Authority (DoA) for technical approvals, ensuring clear accountability for validation results across the global supply chain.

Continuous Improvement and Innovation:

• Standardized Innovation: Drive the adoption of new technologies (e.g., Real-Time Visibility sensors, sustainable materials) by first validating them centrally before rolling them out as new global standards.

• Lean Process Design: Standardize validation workflows to eliminate redundancy across countries, significantly reducing "Time-to-Market" while maintaining strict compliance.

Who you are:

• Bachelor’s degree in Engineering (Packaging, Mechanical, or Chemical) or a related technical field.

• 8+ years of leadership in a highly regulated industry (Pharma/Diagnostics), with a proven track record of setting and enforcing global standards.

• Expert knowledge of ASTM/ISTA standards and global GDP requirements, with the ability to interpret complex regulations into clear, actionable corporate standards.

• Demonstrated experience leading global teams and collaborating cross-functionally with stakeholders at all levels.

• Excellent knowledge of the European, US, China and International regulations and demonstrated ability to adequately interpret and implement standards as related to Supply Chain.

• Demonstrated ability to provide exceptional leadership by consistently role modeling Roche Values, as well as actively demonstrating…