Manufacturing Compliance Specialist

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Regular Full-Time Burlington, MA, US

Manufacturing Compliance Specialist I

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).

The Manufacturing Compliance Specialist I ensures compliant and reliable cell therapy manufacturing through leadership of manufacturing compliance activities including deviation investigations, CAPA implementation, manufacturing documentation, validation support, technology transfer, inspection readiness, and continuous improvement. The role works within approved procedures, partners with the Quality Unit and other site functions, and escalates product, process, safety, and data integrity concerns promptly.

This position is onsite 5 days a week, Monday - Friday, between our Burlington, MA office and our Cambridge office.

Quality Management System

Independently lead routine and moderately complex manufacturing deviation investigations, determine immediate and contributing causes using approved investigation methodologies, develop technically sound corrective actions, and elevate complex or cross‑functional events as appropriate.

Own assigned deviation, CAPA, and change control records from initiation through closure, ensuring investigations, effectiveness checks, and documentation are completed within established timelines.

Apply approved root cause and human performance tools.

Support product, process, equipment, facility, validation, and data impact assessments with Manufacturing and Quality subject matter experts.

Follow current Good Manufacturing Practice, Good Documentation Practice, site procedures, and data integrity requirements when creating, reviewing, correcting, or approving records.

Manufacturing Documentation and Systems

Author and independently revise manufacturing procedures, batch records, forms, and work instructions while assessing impacts to training, validation, and controlled documentation.

Support document periodic review and change implementation to include training impact.

Use applicable manufacturing and quality systems such as MES (E ), ERP, advanced planning, electronic document management, and eQMS in accordance with access, security, and record control requirements.

Manufacturing Support and Process Improvement

Perform routine manufacturing compliance assessments, identify procedural or execution gaps, recommend corrective actions, and partner with functional leaders to implement sustainable improvements.

Support troubleshooting by collecting process information, reviewing available data, and coordinating subject matter input without making unauthorized process changes.

Contribute to Lean and continuous improvement activities while preserving validated state, change control requirements, and product quality controls.

Analyze recurring deviation trends.

Identify systemic process weaknesses.

Lead or co‑lead continuous improvement initiatives.

Use manufacturing metrics to prioritize improvement opportunities.

Support implementation of process robustness improvements.

Training and Inspection Readiness

Maintain personal training and role qualification in a current state.

Coordinate assigned inspection readiness activities, prepare manufacturing documentation, respond to auditor requests, and support regulatory…