Quality Systems Leader — Global Healthcare

Grifols; North Carolina; Sur place; USD 95 000 - 125 000; Plein temps

Avantages offerts par ce poste

Medical benefits

Paid time off

401K match

Tuition reimbursement

Résumé du poste

Grifols is seeking a Quality Systems Manager to lead the donor center's QA program, drive continuous improvement, and ensure regulatory compliance. The role focuses on maintaining quality management systems, SOPs, and staff training to uphold donor safety and product quality.

The candidate will oversee audits, CAPA, and trend analysis while collaborating with center leadership. Strong knowledge of cGMP and FDA regulations is required.

Qualifications

• Bachelor’s degree in science or equivalent; equivalency may replace degree with experience.
• Typically requires 2 years of related experience in a medical or cGMP regulated environment.
• Experience with plasma or whole blood is preferred.

Responsabilités

• Evaluates processes and coordinates strategic implementation of quality system processes and corrective actions at the plasma donor center.
• Maintains oversight of the center’s quality management system and ensures continuous quality improvement by addressing deficiencies promptly.
• Directs and monitors processes to ensure regulatory compliance and implements SOPs for quality control.
• Maintains oversight of training programs, ensuring staff competency and proper documentation.
• Collaborates with Center Manager to assure donor safety, product quality, and regulatory compliance.
• Oversees audits, corrective/preventive actions, and internal/external assessment follow-up.

Formation

Bachelor of Science degree or equivalent

Description du poste

Grifols is seeking a Quality Systems Manager to lead the donor center's QA program, drive continuous improvement, and ensure regulatory compliance. The role focuses on maintaining quality management systems, SOPs, and staff training to uphold donor safety and product quality.

The candidate will oversee audits, CAPA, and trend analysis while collaborating with center leadership. Strong knowledge of cGMP and FDA regulations is required.