Quality Risk Manager – GxP & Data Integrity Lead

Grifols, S.A; Northern (KY); Hybrid; USD 120,000 - 165,000; Full time

Job summary

Grifols, S.A. seeks a Quality Risk Manager to supervise a team of Quality Risk specialists and ensure adherence to quality processes across cGMP and FDA/Grifols Quality Systems. You will manage data integrity, risk assessments, and deviation processes to support Biomat USA quality objectives.

You will collaborate with senior leadership to interpret quality metrics, drive continuous improvement, and oversee regulatory compliance activities. Occasional travel is required.

Qualifications

• BS degree required in life sciences; MS preferred for advanced leadership roles.
• Minimum 4 years of related experience; supervisory/management experience preferred.
• Experience with Quality systems and Regulatory Compliance is desired; plasma industry experience beneficial.

Responsibilities

• Oversee Quality Risk Management processes and QA KPI metrics.
• Collaborate with senior management to analyze donor center and corporate quality data.
• Track and trend inspection/audit observations and propose improvement actions.
• Lead the QAS team to ensure continuous quality improvement and risk mitigation.
• Manage Corporate Deviation Reporting and ensure timely documentation.

Skills

Regulatory writing

CFR knowledge

EP knowledge

Interpersonal skills

Education

BS in life sciences

MS preferred

Tools

Quality systems

Regulatory compliance

Job description

Grifols, S.A. seeks a Quality Risk Manager to supervise a team of Quality Risk specialists and ensure adherence to quality processes across cGMP and FDA/Grifols Quality Systems. You will manage data integrity, risk assessments, and deviation processes to support Biomat USA quality objectives.

You will collaborate with senior leadership to interpret quality metrics, drive continuous improvement, and oversee regulatory compliance activities. Occasional travel is required.