Global Quality Specialist

Job Summary

A company is looking for a Global Quality Specialist responsible for managing logistics documentation and change control within the Quality Management System for a cell therapy supply chain.

Key Responsibilities

• Lead logistics change control activities within the QMS, including impact and risk assessments, approvals, and implementation tracking
• Author and maintain controlled documents such as SOPs and work instructions, ensuring compliance with internal standards and regulatory requirements
• Collaborate with logistics operations and process development teams to translate approved processes into clear documentation and support training enablement

Qualifications

• Bachelor's degree in Supply Chain, Logistics, Life Sciences, Engineering, or a related field; advanced degree preferred
• 6+ years of experience in pharmaceutical or biotech logistics/supply chain with a focus on QMS documentation and change control
• Hands-on experience in logistics operations and cold-chain environments; GMP/GDP experience required
• Proficiency in change control, deviation/CAPA management, and document control processes
• Experience with eQMS/EDMS systems and process mapping tools, along with strong proficiency in Microsoft Excel and PowerPoint