Senior Director, Global Supply Chain & Device Manufacturing

About the Job:

The Senior Director, Global Supply Chain & Device Manufacturing leads a global, cross-site organization spanning the United States and Germany, with responsibility for end-to-end supply chain, device manufacturing, and enterprise lab asset management in a highly regulated environment.

This leader sets the vision, strategy, and operating model for global supply chain, device manufacturing, and asset management at Foundation Medicine. The role requires a balance of strategic thinking and hands-on leadership, with a strong focus on building capabilities that do not yet fully exist, while ensuring operational excellence, regulatory compliance, and reliable delivery across all laboratories and future global sites.

The Senior Director partners closely with Procurement, Quality, Regulatory, Lab Operations, R&D, and external manufacturing partners and serves as a key member of the Global Operations Leadership Team.

Key Responsibilities:

• Lead with people at the center: develop and lead a high-performing, diverse global team, fostering a culture of trust, inclusion, accountability, and continuous development.
• Set and execute a global supply chain, device manufacturing and asset management strategy aligned with Foundation Medicine’s corporate and scientific priorities
• Build a future ready operating model, including foundational capabilities, a sustainable outsourcing and tech transfer strategy for device manufacturing
• Provide strategic leadership for end-to-end supply of critical reagents, consumables, kits, and materials, ensuring reliability, quality, scalability, and cost effectiveness
• Own enterprise lab asset management, including lifecycle management of laboratory equipment (capital assets, maintenance, calibration, service contracts, and compliance), in close alignment with Lab Operations and Technology Operations to drive standardization, efficiency, and scalability
• Champion operational excellence, lean principles, and continuous improvement, driving transformational change across global sites
• Serve as the strategic bridge between Procurement, Product Development, R&D, and Global Operations to influence design decisions, cost of goods, and supply resilience early in development
• Ensure full compliance with IVDR, FDA, and other applicable global regulatory requirements, inclusive of quality systems, audits, documentation, and CAPAs
• Lead S&OP governance, inventory strategy, and global material readiness to support our laboratories and customers worldwide
• Build and maintain strong partnerships with Roche Diagnostics and external manufacturing partners
• Act as a key member of the Global Operations Leadership Team, contributing to enterprise level strategy and execution

Qualifications:

Basic Qualifications:

• Bachelors Degree in Supply Chain, Engineering, Life Sciences, or related field
• 12 years of experience in a regulated industry, with progressive responsibility across supply chain, manufacturing, and/or lab operations
• 5 years of people leadership experience, leading managers and teams in complex, matrixed environments
• Master’s Degree

Preferred Qualifications:

Scope & Domain Experience:

• Experience leading global supply chain and/or regulated manufacturing operations across multiple sites and geographies
• Proven success owning end-to-end supply chain strategy and execution in clinical, diagnostic, or pharmaceutical environments, including R&D support and validation shipping protocols
• Experience managing diagnostic kit, device, or reagent manufacturing operations at scale

Regulatory & Technical Depth:

• Significant experience in regulated reagent or device manufacturing, QC, and distribution, including QSR Design Control and cGMP
• Strong working knowledge of cGMP, GDP, GCP, Annex 13, and IVDR, with experience operating in IVDR manufacturing environments
• Experience defining, implementing, or scaling ERP systems and integrated planning processes

Leadership & Execution Excellence:

• Demonstrated ability to build foundational capabilities, processes, and governance structures where they do not yet exist
• Evidence of exceptional program leadership, managing multiple complex, interdependent initiatives with high operational and regulatory impact
• Strong financial and analytical acumen, including experience developing cost, capacity, and production models
• Highly effective cross functional collaborator, able to influence across Procurement, Quality, Regulatory, R&D, Lab Operations, and external partners
• High emotional intelligence with a people-first leadership approach, and a track record of leading teams through change with clarity, empathy, and accountability

Values & Ways of Working:

• Ability to deliver results in a fast paced, dynamic, and evolving environment without compromising quality or compliance
• Understanding of HIPAA and the importance of protecting patient data and privacy

• Strong alignment with Foundation Medicine values: Integrity, Courage, and Passion

  The expected salary range for this position based on the primary location of Boston, MA is $224,880- $281,100 per year. The salary range is commensurate with Foundation Medicine’s compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.

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