CMC QA Associate: Gene Therapy & cGMP Expert

The Steely Group; Bedford (MA); On-site; USD 130,000 - 180,000; Full time

Job summary

The Steely Group is seeking a CMC QA Consultant to support cross-functional teams across PD, MSAT, CMC, Manufacturing and Regulatory Affairs to ensure quality and compliant controls for gene therapy programs.

You will review batch records, deviations, tech transfers, and regulatory submissions, lead QA oversight of process validation and CMO/QMS activities, and ensure compliance with cGMP throughout development to commercialization.

Qualifications

• BS degree in Engineering or life sciences is required.
• Minimum of 9 years in GMP biopharmaceutical manufacturing.
• Knowledge of FDA/EMA guidelines and ICH.
• Experience authoring/reviewing technical studies.
• Experience leading investigations into deviations and CAPAs.
• Ability to manage cross-functional teams.

Responsibilities

• Provide QA oversight to ensure clinical through commercial development activities meet cGMP requirements.
• Review and approve batch records, deviations, and other quality systems.
• Support review of process characterization studies and related reports.
• Provide oversight of process validation protocols and reports.
• Review tech transfer plans and associated deliverables.
• Author/Review regulatory submissions and responses.
• Support batch disposition and release activities.
• Ensure GMP processes are integrated into the Quality Management System.

Skills

Quality assurance

cGMP knowledge

Regulatory compliance

Auditing / inspections

Root cause analysis

Biopharmaceuticals

Education

Bachelor's degree in a related field

Tools

QMS software

Regulatory submissions tools

Job description

The Steely Group is seeking a CMC QA Consultant to support cross-functional teams across PD, MSAT, CMC, Manufacturing and Regulatory Affairs to ensure quality and compliant controls for gene therapy programs.

You will review batch records, deviations, tech transfers, and regulatory submissions, lead QA oversight of process validation and CMO/QMS activities, and ensure compliance with cGMP throughout development to commercialization.