Senior Project Specialist

Job Summary

A company is looking for a Senior Project Specialist to support technology projects within the Quality and Regulatory Affairs organization.

Key Responsibilities

• Support planning, execution, and delivery of technology projects, ensuring compliance and quality
• Develop and execute validation deliverables and assist in User Acceptance Testing (UAT)
• Collaborate with business process owners to translate needs into technical requirements and maintain compliance with regulatory standards

Required Qualifications

• Bachelor's degree in Life Sciences, Engineering, Information Systems, or a related field
• 5+ years of experience in Quality, Regulatory, or IT project support roles in a life sciences or medical device environment
• Experience with computer system validation (CSV) and GxP-compliant systems
• Familiarity with ERP, eQMS, LIMS, or RIM systems preferred
• Proficient in Microsoft Office, SharePoint, and project collaboration tools