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 the Burlington and Cambridge offices. Ability to work 1 weekend day, and evenings as required.
• Rotating holiday on-call coverage.
• Ability to gown and gain entry to manufacturing areas.

The hourly wage range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $135,000 - $155,000 annually.

The actual salary offered will be determined based on factors such as the candidate's qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above.

In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited.