Senior Quality & Compliance Leader (ISO/GMP/FDA)

ADVATIX - Advanced Supply Chain and Logistics; United States; On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Travel 40%

Job summary

ADVATIX - Advanced Supply Chain and Logistics is seeking a Compliance and Quality Assurance Manager to lead quality systems, regulatory compliance, and audit programs across operations in the United States. You will shape ISO9001, GMP, and FDA compliance, guide risk management, and drive continuous improvement with cross-functional teams.

This role supervises a quality team, partners with operations and clients, manages CAPAs, audits, and training, and reports to senior leadership.

Qualifications

• Bachelor's degree with a focus on quality, regulatory, or related field preferred.
• Minimum 5 years in quality, compliance, regulatory, or operational excellence roles.
• Demonstrated leadership experience managing teams in ISO 9001 environments.

Responsibilities

• Lead development and ongoing improvement of the Quality Management System (QMS).
• Ensure compliance with ISO 9001, GMP, FDA, and customer requirements.
• Manage internal audits and customer/regulatory audits; drive CAPA programs.

Skills

Quality management

ISO standards

CAPA

Root cause analysis

Leadership

Project management

Audits

Documentation

MS Office

Education

Bachelor's degree in Quality Management

Tools

Microsoft Office

Job description

ADVATIX - Advanced Supply Chain and Logistics is seeking a Compliance and Quality Assurance Manager to lead quality systems, regulatory compliance, and audit programs across operations in the United States. You will shape ISO9001, GMP, and FDA compliance, guide risk management, and drive continuous improvement with cross-functional teams.

This role supervises a quality team, partners with operations and clients, manages CAPAs, audits, and training, and reports to senior leadership.