Global Quality & Compliance Specialist

Grifols, S.A; Northern (KY); Hybrid; USD 120,000 - 160,000; Full time

Job summary

Grifols USA seeks a senior quality leader to support the Technical Director in maintaining a compliant Quality System in line with FDA 21 CFR and GDP. You will oversee audits, supplier qualification, change controls, risk assessments, KPIs, and documentation across GUSA to ensure ongoing regulatory compliance.

Responsibilities include supplier/audit programs, CAPA management, quality system improvements, and training coordination to ensure cross-functional integration and timely regulatory

Qualifications

• B.S. in a life science field with extensive quality/regulatory experience.
• Proven track record in GMP/GDP and FDA requirements.
• Experience leading cross-functional teams and audits.

Responsibilities

• Lead supplier and distributor audits to ensure GDP compliance.
• Maintain Quality System documentation, change controls, and risk assessments.
• Oversee CAPAs, deviations, and complaint handling across sites.
• Manage distribution quality records and traceability programs.
• Coordinate training and update procedures for regulatory alignment.

Skills

Quality systems

Regulatory compliance

Auditing

Leadership

Training coordination

Education

B.S. in life science or related field

Tools

Veeva QMS

Job description

Grifols USA seeks a senior quality leader to support the Technical Director in maintaining a compliant Quality System in line with FDA 21 CFR and GDP. You will oversee audits, supplier qualification, change controls, risk assessments, KPIs, and documentation across GUSA to ensure ongoing regulatory compliance.

Responsibilities include supplier/audit programs, CAPA management, quality system improvements, and training coordination to ensure cross-functional integration and timely regulatory