Sr. Manufacturing Compliance Specialist

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). **Position Summary:** The Manufacturing Compliance Specialist serves as the compliance subject matter expert within Manufacturing, ensuring cell therapy operations are executed in accordance with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality systems. This position partners closely with Manufacturing, Quality Assurance, Quality Control, Process Analytical and Development, Engineering, Validation, and Supply Chain to investigate manufacturing events, implement process improvements, and support reliable, inspection-ready manufacturing operations. This role requires strong Quality Management System (QMS) expertise, the ability to lead cross-functional initiatives without direct authority, and a solid technical understanding of cell therapy manufacturing processes. **Schedule:** This position is onsite Monday through Friday from 8:00 AM to 5:00 PM, and will require splitting time approximately 50/50 between our Burlington, MA and Cambridge, MA offices. As we continue to transition to our new facility in Burlington, this will eventually shift to a 80/20 split between Burlington and Cambridge. Once per quarter, you may also be required to work a weekend. **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 **Basic Qualifications:** - BA/BS 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:** - 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 **Working Conditions & Physical Demands:** - Schedule is Monday - Friday split between th…