Global Quality & Compliance Lead — GDP & Audits

Grifols, S.A; Durham (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

Grifols USA (GUSA) seeks a Quality Systems professional to support the Technical Director in maintaining a compliant Quality System for FDA 21 CFR and GDP. The role manages audits, supplier and distributor qualification, change controls, risk assessments, KPIs, and quality system documentation to ensure ongoing regulatory compliance.

The position requires strong leadership, cross-functional collaboration, and a proven track record in medical device or pharmaceutical regulated environments.

Qualifications

• BS in life sciences or related field required.
• Experience with GDP and FDA device/biologics requirements.
• Ability to lead audits and cross-functional teams.
• Strong documentation and regulatory compliance track record.

Responsibilities

• Conduct supplier audits to ensure GDP and regulatory compliance.
• Perform internal audits of quality systems per GDP.
• Support CAPAs, deviations, and complaints with timely resolution.
• Maintain distribution quality records and traceability.
• Manage distributor qualification and 3PL validation per regulatory requirements.
• Oversee change controls within the Veeva QMS.
• Develop training and ensure procedures are updated.
• Maintain KPI monitoring and reporting.

Skills

Quality Assurance

GDP Compliance

FDA Regulations

Leadership

Audits

Education

Bachelor's degree in life sciences

Tools

Veeva QMS

Job description

Grifols USA (GUSA) seeks a Quality Systems professional to support the Technical Director in maintaining a compliant Quality System for FDA 21 CFR and GDP. The role manages audits, supplier and distributor qualification, change controls, risk assessments, KPIs, and quality system documentation to ensure ongoing regulatory compliance.

The position requires strong leadership, cross-functional collaboration, and a proven track record in medical device or pharmaceutical regulated environments.