Global Supplier Quality Auditor

Lancesoft; Lewisville (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Lancesoft seeks a Supplier Quality Management professional to assure outsourced product quality and regulatory compliance across global suppliers. You will manage supplier data, drive audits, and oversee CAPA processes in alignment with GMP and FDA requirements.

The role requires on-site work, strong data management skills, and collaboration across multiple departments to maintain supplier quality excellence.

Qualifications

• Knowledge of current GMPs, GLPs, ICH Q7, ICH Q10, ICH Q9, 21 CFR Part 11, and 21 CFR Parts 111, 210 and 211.

Responsibilities

• Maintain manufacturer/supplier data in Agile and ensure data accuracy for supplier assessments.
• Conduct audits of global manufacturers and suppliers to ensure quality and regulatory compliance.
• Support supplier quality audits, CAPA review, escalation, and effectiveness verification.
• Serve as a corporate supplier quality resource and collaborate across functions to meet MKI policies.

Skills

GMPs knowledge

GLPs knowledge

ICH Q7 knowledge

ICH Q10/Q9 knowledge

FDA regulations familiarity

Project management

data analysis

communication skills

Tools

MS Word

Excel

Outlook

Teams

Job description

Lancesoft seeks a Supplier Quality Management professional to assure outsourced product quality and regulatory compliance across global suppliers. You will manage supplier data, drive audits, and oversee CAPA processes in alignment with GMP and FDA requirements.

The role requires on-site work, strong data management skills, and collaboration across multiple departments to maintain supplier quality excellence.