Sr. Manufacturing Compliance Specialist
Vericel Corporation
August 14, 2026
On-site
Burlington, MA
Operations
Position Summary
The Manufacturing Compliance Specialist serves as the compliance subject matter expert within Manufacturing, ensuring cell therapy operations are executed in accordance with cGMP, regulatory requirements, and internal quality systems.
Schedule
Onsite Monday–Friday, 8:00 AM–5:00 PM; split ~50/50 between Burlington, MA and Cambridge, MA (eventually ~80/20 Burlington/Cambridge). May require 1 weekend day per quarter.
Key Responsibilities
Quality Management System
- Lead complex 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, data integrity principles (ALCOA+), and internal quality systems.
- Support regulatory inspection readiness and audit responses.
Technical Expertise
- Provide technical support/troubleshooting for cell therapy manufacturing processes.
- Author and revise manufacturing documentation (SOPs, batch records, job aids).
- Support manufacturing projects and process validation.
- Review manufacturing operations for compliance and process improvement opportunities.
- Maintain expertise in aseptic processing, cleanroom operations, and BSC practices.
Project Leadership and Continuous Improvement
- Lead cross-functional projects to completion without direct authority.
- Partner with cross-functional teams to resolve technical and compliance issues.
- Drive project timelines, identify risks, and communicate status.
- Support Lean/Continuous Improvement initiatives.
- Support digital manufacturing system implementations/enhancements (EBR, MES, ERP, electronic QMS).
Basic Qualifications
- BA/BS in a scientific discipline or equivalent experience (preferred).
- 5+ years in a biopharmaceutical manufacturing environment.
- Familiarity with OpCenter, ERP, EBR, TrackWise, and Veeva.
- Familiar with biopharmaceutical equipment and manufacturing systems.
- Strong knowledge of cGMP and regulatory requirements.
- Excellent written and verbal communication.
- Demonstrated experience leading cross-functional projects.
Preferred Qualifications
- PMP Certified.
- Lean Six Sigma certification or experience.
- Root Cause Analysis, GEMBA Problem Solving (or equivalent) certification/experience.
- Human Error Prevention Programs (HEPP) experience.
- Basic laboratory skills (including mammalian cell culture).
- Experience in cell therapy or aseptic manufacturing.
Working Conditions
- Ability to gown and enter manufacturing areas.
- Rotating holiday on-call coverage; evenings as required.
The Manufacturing Compliance Specialist serves as the compliance subject matter expert within Manufacturing, ensuring cell therapy operations are executed in accordance with cGMP, regulatory requirements, and internal quality systems.
Schedule
Onsite Monday–Friday, 8:00 AM–5:00 PM; split ~50/50 between Burlington, MA and Cambridge, MA (eventually ~80/20 Burlington/Cambridge). May require 1 weekend day per quarter.
Key Responsibilities
Quality Management System
- Lead complex 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, data integrity principles (ALCOA+), and internal quality systems.
- Support regulatory inspection readiness and audit responses.
Technical Expertise
- Provide technical support/troubleshooting for cell therapy manufacturing processes.
- Author and revise manufacturing documentation (SOPs, batch records, job aids).
- Support manufacturing projects and process validation.
- Review manufacturing operations for compliance and process improvement opportunities.
- Maintain expertise in aseptic processing, cleanroom operations, and BSC practices.
Project Leadership and Continuous Improvement
- Lead cross-functional projects to completion without direct authority.
- Partner with cross-functional teams to resolve technical and compliance issues.
- Drive project timelines, identify risks, and communicate status.
- Support Lean/Continuous Improvement initiatives.
- Support digital manufacturing system implementations/enhancements (EBR, MES, ERP, electronic QMS).
Basic Qualifications
- BA/BS in a scientific discipline or equivalent experience (preferred).
- 5+ years in a biopharmaceutical manufacturing environment.
- Familiarity with OpCenter, ERP, EBR, TrackWise, and Veeva.
- Familiar with biopharmaceutical equipment and manufacturing systems.
- Strong knowledge of cGMP and regulatory requirements.
- Excellent written and verbal communication.
- Demonstrated experience leading cross-functional projects.
Preferred Qualifications
- PMP Certified.
- Lean Six Sigma certification or experience.
- Root Cause Analysis, GEMBA Problem Solving (or equivalent) certification/experience.
- Human Error Prevention Programs (HEPP) experience.
- Basic laboratory skills (including mammalian cell culture).
- Experience in cell therapy or aseptic manufacturing.
Working Conditions
- Ability to gown and enter manufacturing areas.
- Rotating holiday on-call coverage; evenings as required.