Senior Cell Therapy Compliance Lead, cGMP/QA

Scorpion Therapeutics; Burlington (MA); On-site; USD 70,000 - 95,000; Full time

Job summary

Scorpion Therapeutics in Burlington, MA, is seeking a Manufacturing Compliance Specialist to ensure compliance in cell therapy operations. This role involves leading deviation investigations, managing quality systems, and technical support for manufacturing processes.

The ideal candidate will have a BA/BS in a scientific field, 3–6 years in biopharmaceutical manufacturing, and a solid understanding of cGMP regulations. Working conditions require onsite presence Monday to Friday, with occasional weekend work.

Qualifications

• 3–6 years of experience in biopharmaceutical manufacturing.
• Strong knowledge of cGMP and regulatory requirements.
• Excellent written and verbal communication skills.

Responsibilities

• Lead deviation investigations using structured root cause analysis.
• Ensure compliance with cGMP, data integrity, and internal quality systems.
• Drive project timelines and manage risks in cross-functional projects.

Skills

cGMP compliance

Cross-functional project leadership

Technical support for manufacturing processes

Quality Management Systems

Education

BA/BS in a scientific discipline

Tools

OpCenter

ERP

TrackWise

Veeva

Job description

Scorpion Therapeutics in Burlington, MA, is seeking a Manufacturing Compliance Specialist to ensure compliance in cell therapy operations. This role involves leading deviation investigations, managing quality systems, and technical support for manufacturing processes.

The ideal candidate will have a BA/BS in a scientific field, 3–6 years in biopharmaceutical manufacturing, and a solid understanding of cGMP regulations. Working conditions require onsite presence Monday to Friday, with occasional weekend work.