project temperature strategy

Project Temperature Strategy & Execution Lead The Project Temperature Strategy & Execution Lead manages temperature strategy and execution activities for Medicine clinical supplies, including Drug Product and Finished Kits, across all clinical trial phases. This role ensures compliant temperature management in line with GMP, GDP, GCP, regulatory requirements, and internal procedures, and serves as a subject matter expert for temperature excursions, passive shipper strategy, audit readiness, and process improvement within Clinical Supply Chain.
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key responsibilities
Temperature Strategy, Compliance, and Governance
- Oversee Temperature Strategy & Execution governance across Clinical Supply Chain and partner organizations, including Quality, Drug Product Development, Analytical Development, Global Clinical Operations, Logistics, and external partners.
- Ensure temperature management activities are performed in alignment with global standards, SOPs, GxP, Quality, and Regulatory guidelines to support compliant clinical trial execution. Audit, Inspection, and Regulatory Support
- Act as audit spokesperson and subject matter expert for Temperature Strategy & Execution topics across regions, including audit preparation, front-room support, and response development. Passive Shipper Strategy and Documentation
- Lead the development, implementation, and continuous improvement of passive shipper strategy for clinical supply distribution.
- Coordinate quote requests, purchase order setup, and central sourcing of passive shippers for Clinical Supply Chain-managed distribution of investigational medicinal products.
- Provide expert support on passive shipper requirements, study drug transport conditions, and temperature management expectations.
- Own passive shipper documentation, including reviews, updates, and supporting materials to ensure audit readiness and process consistency.
- Project, Process, and Issue Management
- Lead strategic initiatives and assigned projects using FPX and project management best practices to drive process excellence within Clinical Supply Chain.
- Identify and implement process and business improvements in collaboration with cross-functional partners. Conduct issue resolution activities, including root cause analysis, metric review, and process evaluation related to temperature excursion management.
- Support portfolio changes, new clinical trials, evolving supply strategies, new modalities, licensing and acquisition activities, and business integrations.
- Stakeholder and Partner Management
- Collaborate with internal business partners such as Planning, Quality, Procurement, Clinical Supply Integrators, and Trial Supply Leads to shape sourcing strategies and decisions to mitigate risk, ensure reliable supply, and balance cost with other sourcing considerations.
- qualifications

Education:
Minimum of a Bachelor's Degree in Business or Science is required. Master’s Degree and/or related supply chain certification is preferred (e.g. APICS). Required Skills/Experience:
- A minimum of 5 years of related experience is required.
- Experience in clinical supply chain, logistics, temperature-controlled distribution, quality, regulatory compliance, or a related pharmaceutical environment is required.
- Strong knowledge of GxP requirements, temperature management principles, clinical trial supply processes, and investigational medicinal product distribution is preferred.
- Strong leadership skills. Ex: Managing complexity, conflict, and ability to identify process gaps based on data or root cause analysis, ability to predict risk/impact of supply related processes.
- Strong communication, stakeholder management, influencing, and problem-solving skills, including the ability to represent the function during audits, inspections, and senior stakeholder interactions. Key Competencies The successful candidate will demonstrate leadership, accountability, attention to detail, strategic thinking, risk-based decision-making, collaboration, and effective communication in a global, regulated clinical supply environment. share this job.