Global Lead for Packaging & Route Validation Standards
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The Position
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 capabilities and behaviors specific to Roche Leadership Framework (Leadership Commitments, Creative Leadership, VACC) and Operating Principles.
Strong strategic and operational decision-making with a proven ability to lead and drive global projects in a complex, culturally diverse and dynamic environment through a strong solution-oriented approach along with a strong ability to coach others to do the same.
This role can be on-site or hybrid or fully remote
Relocation benefits are not available for this posting
The expected salary range for this position based on the primary location of Indianapolis, IN is $125,700 - $233,500. 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 based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits
Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Indianapolis. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche 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, individuals with disabilities status, and consistent with all federal, state, or local laws.
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