Supply Chain Specialist

Partner with Supply Chain, Quality, Process Development, and Manufacturing teams to ensure change controls meet Quality Management System requirements and are implemented within established timelines. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners.

The Fountain Group is currently seeking a Senior Supply Chain Specialist for a prominent client of ours. This position is located in Santa Monica, CA. Details for the position are as follows:

Job Title: Senior Supply Chain Specialist – Change Control Owner
Location: Santa Monica, CA (Hybrid; transition to El Segundo in 2027)
Pay Rate: $78.78/hr
Duration: 1 Year

Job Description

Own and manage Global Supply Chain (GSC) initiated change controls within a GMP/GxP environment. Partner with Supply Chain, Quality, Process Development, and Manufacturing teams to ensure change controls meet Quality Management System requirements and are implemented within established timelines.

• Own GSC change control records from initiation through pre-implementation, implementation, and post-implementation.
• Define, plan, track, and implement change control activities across global and regional supply chain operations.
• Maintain change control records, timelines, approvals, dependencies, risks, and mitigation actions.
• Coordinate change control meetings and track related tasks and milestones within project plans.
• Partner with Quality to ensure compliance with governing QMS procedures and standards.
• Monitor change control progress, escalate delays and risks, and support timely resolution.
• Apply change management principles to support implementation and sustainment of operational changes.
• Identify and support continuous improvement initiatives for Change Control and Supply Chain operations.

Education

• Master's degree with 3+ years of Supply Chain, Change Control, or Operations experience; or
• Bachelor's degree with 5+ years of relevant experience; or
• Associate's degree with 7+ years of relevant experience; or
• High School Diploma/GED with 9+ years of relevant experience.

Required Skills

• GMP/GxP Change Control Management
• Quality Management Systems (QMS)
• Supply Chain Change Control
• Change Control Records and Lifecycle Management
• Pharmaceutical/Biotechnology/Cell & Gene Therapy experience
• QMS procedures, compliance, and quality records
• Pre-implementation, implementation, and post-implementation change control activities
• Change Management principles and methodology
• Change Control tracking, risk management, and escalation
• Project milestone and dependency tracking
• Veeva QMS, TrackWise, or Oracle Agile QMS
• Supply Chain operations within a regulated life sciences environment

Preferred Skills

• 1+ year as a practitioner of GMP Change Control
• 2+ years of Change Control experience in a GxP environment
• Veeva QMS
• Oracle Agile QMS
• TrackWise
• Smartsheet
• MS Project
• Visio
• PowerPoint / Microsoft Office
• Experience with pharmaceutical, biotech, cell and gene therapy, or medical device operations
• Demonstrated expertise in Change Control processes, procedures, and methodology

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