Cold Chain Operations Compliance & Continuous Improvement Specialist

Project Overview
The Cold Chain Operations (CCO) team is seeking a consultant to support the advancement of quality, compliance, and operational efficiency across external supply and cold chain processes. This role will focus on establishing structured change management practices, executing critical quality processes, and driving continuous improvement initiatives to enhance system performance, reporting, and overall operational effectiveness.
Project Goal
Establish and execute a scalable Cold Chain Operations framework that enables compliant change management, efficient deviation resolution, and measurable continuous improvement across external supply activities, while optimizing tools, processes, and governance aligned with CCO leadership priorities.
Key Deliverables
• Change Management Framework Development & Execution
Establish and implement structured change management processes for Cold Chain Operations, including ownership and execution of External Supply change controls within designated systems. Ensure all changes are documented, approved, and executed in compliance with applicable quality standards and procedures.
• Deviation, NC/CAPA Resolution & Compliance Oversight
Execute and manage nonconformance (NC) and CAPA activities related to Cold Chain Operations, ensuring timely resolution, thorough documentation, and adherence to internal and regulatory requirements. Provide visibility into issue trends and support proactive remediation strategies.
• Continuous Improvement & Operational Optimization Initiatives
Lead and deliver Continuous Improvement (CI) initiatives across CCO, including development of standardized tools, enhanced workflows, and optimization of existing processes. Drive measurable reductions in operational inefficiencies and support implementation of improved governance structures (e.g., SRV playbook development).
• SRV Process Coordination & Tool Enhancement
Support Shipping Route Verification (SRV) operations by acting as a central coordinator (triage lead), ensuring alignment across stakeholders, adherence to timelines, and accurate documentation. Identify process gaps and develop recommendations for system and tool enhancements (e.g., COMET reporting improvements, next-generation tool deployment).
• Cold Chain Documentation Lifecycle Management
Manage the full lifecycle of Cold Chain-related documentation, including creation, revision, and obsolescence, ensuring all documentation is current, audit-ready, and aligned with operational and regulatory requirements.

Key Responsibilities
• Execute change controls, deviations, and CAPA activities within Cold Chain Operations systems
• Partner cross-functionally with Quality, Supply Chain, and External Partners to drive alignment and execution
• Develop and implement system and reporting enhancements (e.g., COMET or related platforms)
• Lead process mapping, gap assessments, and implementation of optimized workflows
• Support development of governance frameworks and operational playbooks for CCO processes
• Coordinate and track progress of cross-functional operational activities (e.g., SRVs), ensuring accountability and completion
• Provide data-driven insights and recommendations to CCO leadership

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

• Strong experience in GxP-regulated environments (pharma/biotech preferred)
• Demonstrated expertise in change control, deviations, and CAPA management
• Experience supporting Cold Chain Operations, External Supply, or related supply chain functions
• Ability to lead continuous improvement / business process optimization initiatives
• Strong project management and stakeholder coordination capabilities
• Experience working with quality and documentation systems (e.g., TrackWise, Veeva, COMET, or similar)

• Background in cold chain/logistics or temperature-controlled supply chain
• Experience supporting Shipping Route Verifications (SRVs) or similar qualification processes
• Familiarity with system/reporting optimization and automation initiatives
• Proven ability to operate in cross-functional, matrixed environments with minimal oversight

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.