GxP Inspection Lead — Quality & CAPA Expert

Scorpion Therapeutics; Town of Vermont (WI); On-site; USD 170,000 - 210,000; Full time

Job summary

Scorpion Therapeutics seeks a Site Self Inspection Lead to develop, execute, and track site self-inspection plans ensuring regulatory compliance and continuous improvement.

You will lead internal inspections, oversee CAPA, prepare trend reports, support audit readiness, and conduct external audits of suppliers while training staff on GMP and inspection processes.

This role requires a Bachelor’s in Science or Engineering and 10+ years in GXP with knowledge of global regulations and quality systems.

Qualifications

• 10+ years' experience in GXP settings with extensive knowledge of pharmaceutical cGMP and global regulations.
• Experience with quality systems and CAPA processes.
• Familiarity with GMP training and inspection protocols.

Responsibilities

• Lead and participate in internal inspections.
• Oversee CAPA development and verification.
• Prepare trend reports and audit readiness documentation.
• Conduct external audits of third-party suppliers.
• Provide training on GMP and inspection processes.
• Support quality culture initiatives.

Skills

GxP knowledge

cGMP

CAPA management

Audit readiness

Regulatory knowledge

Education

Bachelor's degree in Science/Engineering

Job description

Scorpion Therapeutics seeks a Site Self Inspection Lead to develop, execute, and track site self-inspection plans ensuring regulatory compliance and continuous improvement.

You will lead internal inspections, oversee CAPA, prepare trend reports, support audit readiness, and conduct external audits of suppliers while training staff on GMP and inspection processes.

This role requires a Bachelor’s in Science or Engineering and 10+ years in GXP with knowledge of global regulations and quality systems.