Archived listing. The details below describe a past opening.
Required Skills & Experience
5+ years supporting pharmaceutical, biotech, medical device, or regulated supply chain environments Experience supporting GxP-regulated operations Experience working with Learning Management Systems Experience managing training curricula, qualification records, and compliance activities Experience supporting deviations, CAPAs, change controls, investigations, or quality systems Strong documentation management and governance experience Experience working with systems such as SUMMIT, COMET, TruVault, TrackWise, Veeva, or equivalent platforms Excellent stakeholder management and cross-functional coordination skills Strong organizational, reporting, and project management capabilities
Nice to Have Skills & Experience
Cold Chain Operations Supply Chain Quality External Manufacturing Distribution Quality Shipping Route Verification (SRV) Training Center of Excellence support models Process improvement and workflow optimization initiatives Automation and digital transformation projects
Job Description
The organization is seeking a consultant to support the establishment of a centralized operational support model across Cold Chain, External Supply, and Global Deliver functions. This individual will serve as a key contributor in creating scalable processes around training administration, documentation governance, quality system coordination, and operational support activities. The role will initially support critical training administration needs while expanding into broader operational responsibilities across change controls, investigations, documentation management, SRV coordination, and continuous improvement initiatives. This position is intended to help establish the foundation for a future global Center of Excellence supporting Deliver's worldwide operations. Project Goal Establish and execute a scalable operational support framework that enables compliant training management, documentation governance, quality system coordination, and administrative process ownership while reducing dependency on individual SMEs and improving visibility, standardization, and operational efficiency across Deliver. Training Governance & Administration Execute global training administration activities within SUMMIT Manage curricula, training assignments, qualification records, and learning plans Coordinate onboarding, role transitions, and training compliance requirements Monitor and report training completion metrics across Deliver organizations Support inspection readiness through compliant training documentation management Documentation Governance & Quality Systems Support Support lifecycle management of Deliver documentation, including creation, revision, approval coordination, and obsolescence activities Assist with change controls, deviations, CAPAs, investigations, and related quality system activities Maintain documentation visibility and governance across global teams Ensure inspection-ready documentation and compliance records Operational Coordination & Administrative Support Serve as a centralized coordinator for operational activities across Deliver functions Support work intake, task tracking, stakeholder coordination, and status reporting Assist with planning, scheduling, capacity visibility, and operational governance activities Coordinate cross-functional activities involving Cold Chain, External Supply, Quality, and Supply Chain teams Process Standardization & Continuous Improvement Identify opportunities to standardize processes currently dependent on individual SMEs Develop work instructions, process documentation, and governance frameworks Support implementation of scalable operational workflows Participate in automation and process improvement initiatives supporting SRV, documentation management, and administrative processes Reporting & Performance Metrics Develop dashboards and reporting supporting training compliance, operational performance, and process effectiveness Monitor key metrics related to investigations, documentation, training compliance, and operational support activities Provide data-driven insights and recommendations to Deliver leadership Support visibility into workload, cycle times, compliance status, and process trends