Sr. Manufacturing Compliance Specialist
Job in
Burlington, Middlesex County, Massachusetts, 01805, USA
Listed on 2026-07-08
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-07-08
Job specializations:
-
Manufacturing / Production
Quality Engineering, Validation Engineer, Pharmaceutical Manufacturing
Job Description & How to Apply Below
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.
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, data integrity (ALCOA+), and internal quality systems
- Support regulatory inspection readiness and audit responses
- 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 to identify compliance and process improvement opportunities
- Maintain expertise in aseptic processing, cleanroom operations, and BSC practices
- Lead cross-functional projects to completion without direct authority
- Partner cross-functionally to resolve technical and compliance issues
- Drive project timelines, manage risks, and communicate status
- Support Lean/Continuous Improvement initiatives
- Support implementation/enhancements of manufacturing systems (E , MES, ERP, electronic QMS)
- BA/BS in a scientific discipline (or equivalent experience)
- 3–6 years in biopharmaceutical manufacturing
- Familiarity with OpCenter, ERP, E , Track Wise, Veeva
- Knowledge of biopharmaceutical equipment/manufacturing systems
- Strong knowledge of cGMP and regulatory requirements
- Excellent written/verbal communication
- Demonstrated experience leading cross-functional projects
- Lean Six Sigma certification/experience
- Root Cause Analysis or GEMBA Problem Solving (certification/experience)
- HEPP experience; basic lab skills (mammalian cell culture)
- Cell therapy or aseptic manufacturing experience
- Onsite Mon–Fri 8am–5pm; split ~50/50 between Burlington, MA and Cambridge, MA (eventually ~80/20 Burlington/Cambridge)
- May work one weekend day per quarter; evenings as required; rotating holiday on-call
- Ability to gown and enter manufacturing areas
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