Plasma Center Quality Lead & Compliance

Grifols, S.A; Aurora (CO); On-site; USD 69,000 - 103,000; Full time

Benefits offered by this job

Relocation assistance

Bonus pool eligibility (up to 20%)

Job summary

Grifols, S.A in Aurora, CO is seeking a Quality Systems Manager for its plasma center to lead the quality management system, ensure regulatory compliance, and drive continuous improvement.

The role reports to the Regional Quality Manager and requires strong knowledge of cGMP, FDA regulations, and donor safety processes. Relocation aid is available, with a competitive bonus pool potential.

Qualifications

• Command of interpersonal communication and problem-solving.
• Ability to understand and assess FDA regulations.
• Strong organizational skills and attention to detail.

Responsibilities

• Oversees the center's quality management system and continuous quality improvement.
• Directs and monitors processes to ensure regulatory compliance and SOP implementation.
• Collaborates with Center Manager to maintain product quality, donor safety, and suitability.
• Manages Quality Systems Associate staffing, training, and performance.
• Oversees audits, CAPA, and corrective actions; reviews adverse events and deviations.
• Maintains training compliance (e.g., cGMP, BBP) and staff competency.

Skills

Interpersonal communication

Organizational skills

Problem-solving

FDA regulations understanding

Education

Bachelor of Science degree or equivalent

Certified in quality and compliance

Job description

Grifols, S.A in Aurora, CO is seeking a Quality Systems Manager for its plasma center to lead the quality management system, ensure regulatory compliance, and drive continuous improvement.

The role reports to the Regional Quality Manager and requires strong knowledge of cGMP, FDA regulations, and donor safety processes. Relocation aid is available, with a competitive bonus pool potential.