Global QA & Compliance Audit Lead

Ergomed; United States; A distancia; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Ergomed is seeking a Quality Manager to lead audit programs and drive quality across the organization. The role focuses on designing and managing internal and vendor audits, ensuring adherence to GxP regulations and risk-based strategies, and partnering with procurement and operations to uphold high quality standards.

The ideal candidate has 3+ years of GCP/GVP auditing experience and 2+ years in audit program management, with strong organizational and communication skills and fluent English.

Formación

• Experience with GVP and GCP regulatory requirements or willingness to broaden.
• At least 3 years of direct auditing experience in GCP and/or GVP.
• At least 2 years in audit program management including risk-based audit plans.

Responsabilidades

• Lead internal and vendor audits following the Audit Plan and manage pre/post-audit activities.
• Develop and maintain the internal Quality Risk Assessment methodology and Audit Universe.
• Ensure compliance with laws and regulations including US FDA CFRs, GVP, ICH-E6, and related standards.
• Collaborate with Vendor Management and operations to drive risk-based audit strategy.

Conocimientos

Organization skills

Attention to details

Communication facilitation

Proactive

Fluent in English

Educación

Bachelor's or Master's degree in biomedical sciences

Descripción del empleo

Ergomed is seeking a Quality Manager to lead audit programs and drive quality across the organization. The role focuses on designing and managing internal and vendor audits, ensuring adherence to GxP regulations and risk-based strategies, and partnering with procurement and operations to uphold high quality standards.

The ideal candidate has 3+ years of GCP/GVP auditing experience and 2+ years in audit program management, with strong organizational and communication skills and fluent English.