CMC QA Lead - Gene Therapy & Regulatory Readiness

The Steely Group; Bedford (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

The Steely Group seeks a CMC QA Consultant to provide quality oversight across gene therapy programs, collaborating with PD, MSAT, CMC, Manufacturing and Regulatory Affairs to ensure cGMP compliance from clinical to commercial stages.

Reporting to the Director of CMC QA, you will review batch records, deviations, tech transfer plans, and regulatory submissions, while leading investigations and supporting CMOs to sustain product quality and continuous process improvements.

Qualifications

• BS degree in Engineering, Biotechnology, Biological/Physical sciences or equivalent.
• Minimum of 9 years' GMP biopharmaceutical manufacturing/QA experience.
• Strong knowledge of FDA/EMA and ICH guidelines.
• Experience authoring/reviewing technical studies and regulatory submissions.
• Experience with deviations, CAPA, change controls and batch disposition.
• Ability to lead investigations and drive continuous improvement.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Quality Assurance Lead for cross-functional CMC sub-teams.
• Review and approve batch records, deviations, and quality systems.
• Provide oversight of process validation protocols and reports.
• Author/review CMC sections of regulatory dossiers.
• Support batch disposition and release activities for clinical and commercial products.
• Ensure GMP processes are embedded in the QMS.
• Liaise with CMOs and regulatory authorities.

Skills

Quality Assurance

CMC

GMP

Regulatory Affairs

Quality Systems

Cross-functional Collaboration

Root Cause Analysis

Process Improvement

Documentation

Education

BS degree in Engineering/ Biotechnology/ Biological/ Physical sciences

Job description

The Steely Group seeks a CMC QA Consultant to provide quality oversight across gene therapy programs, collaborating with PD, MSAT, CMC, Manufacturing and Regulatory Affairs to ensure cGMP compliance from clinical to commercial stages.

Reporting to the Director of CMC QA, you will review batch records, deviations, tech transfer plans, and regulatory submissions, while leading investigations and supporting CMOs to sustain product quality and continuous process improvements.