cGMP Project Lead — Quality & Compliance

Houston Methodist; Houston (TX); On-site; USD 85,000 - 110,000; Full time

Job summary

Houston Methodist seeks a cGMP Specialist Project Specialist to drive manufacturing projects within the Office of Translational Production and Quality. You will liaison between clients and internal operations, develop plans, track resources, manage budgets, and organize regular update meetings for project teams to ensure milestones are met.

The role emphasizes SOP/cGMP adherence, review of procedures, equipment validation, and inspections support, with collaboration across QA, process

Qualifications

• Bachelor’s degree in a relevant field; Master’s degree preferred.
• Minimum three years of experience in biotech/pharma with cGMP exposure.
• Experience performing IQ/OQ/PQ, audits and inspections preferred.
• Familiarity with FDA regulations and GLP/cGMP concepts.
• Proficiency with MS Office and presentation software.

Responsibilities

• Develop and manage project plans, track milestones and deliverables.
• Coordinate cross-functional teams to meet quality and compliance goals.
• Assist in audits, regulatory inspections and deviation investigations.
• Serve as liaison between clients and internal operations to ensure clarity.

Skills

Clear communication

Regulatory awareness

Project coordination

Cross-functional collaboration

Attention to detail

Prioritization under pressure

Education

Bachelor’s degree

Master’s degree preferred

Job description

Houston Methodist seeks a cGMP Specialist Project Specialist to drive manufacturing projects within the Office of Translational Production and Quality. You will liaison between clients and internal operations, develop plans, track resources, manage budgets, and organize regular update meetings for project teams to ensure milestones are met.

The role emphasizes SOP/cGMP adherence, review of procedures, equipment validation, and inspections support, with collaboration across QA, process