Sr. Manufacturing Compliance Specialist

Key Responsibilities

• Quality Management System Lead deviation investigations using structured root cause analysis
• Author and manage deviations, CAPAs, and Change Controls through closure
• Perform impact and risk assessments to support manufacturing changes
• Ensure compliance with cGMP requirements, data integrity principals (ALCOA+), and internal quality systems
• Support regulatory inspection readiness and audit responses

Technical Expertise

• Provide technical support and troubleshooting for cell therapy manufacturing processes
• Author and revise manufacturing documentation (e.g. SOPs, batch records, job aids…)
• Support manufacturing projects, process validation
• Review manufacturing operations to identify compliance and process improvement opportunities
• Maintain expertise in aseptic processing, cleanroom operations, and BSC practices

Project Leadership and Continuous Improvement

• Lead cross functional projects and drive initiatives to completion without direct authority
• Partner with CFT (e.g. Manufacturing, Quality, QC, Engineering, Development teams…) to resolve technical and compliance issues
• Drive project timelines, identify risks, and communicate status to stakeholders
• Support Lean and Continuous Improvement initiatives to enhance quality and operational performance
• Support implementation and enhancements of manufacturing systems to include EBR, MES, ERP and electronic QMS

Qualifications

• Bachelor's degree in a scientific discipline or equivalent experience preferred
• 3-6 years of experience in a biopharmaceutical manufacturing environment
• Familiarity with computer systems such as OpCenter, ERP, EBR, TrackWise and Veeva
• Must be familiar with biopharmaceutical equipment and manufacturing systems
• Strong knowledge of Current Good Manufacturing Practices and regulatory requirements
• Excellent communication skills, written and verbal
• Demonstrated experience leading cross functional projects

Preferred Qualifications

• Leverage Lean Six Sigma Certification or Experience
• Root Cause Analysis, GEMBA Problem Solving or equivalent certification or experience
• Experience with Human Error Prevention Programs (HEPP)
• Basic laboratory skills, including working with mammalian cell culture
• Experience in cell therapy or aseptic manufacturing