Quality Systems Lead — GMP Compliance & Training

Grifols; Rock Hill (SC); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical benefits

PTO

401K match

Tuition reimbursement

Job summary

Grifols in Rock Hill, SC is seeking a Quality Systems Manager to lead the center's quality management program, implement corrective actions, and ensure compliance with FDA and cGMP requirements.

You will oversee audits, training, document control, and collaboration with the Center Manager to maintain product quality and donor safety. Requires BS and 2 years in a medical/cGMP setting; plasma experience preferred.

We offer benefits and opportunities for growth within a global healthcare company.

Qualifications

• Bachelor of Science degree or equivalent.
• Typically requires 2 years of related experience in a medical and/or cGMP regulated environment.
• Experience with plasma or whole blood preferred.

Responsibilities

• Evaluates processes and coordinates strategic implementation of quality system processes and corrective actions.
• Maintains oversight of the quality management system and drives continuous quality improvement.
• Directs and monitors compliance with state, federal, and company SOPs for quality control and regulatory compliance.
• Oversees staff training records and competency.
• Collaborates with Center Manager to assure donor center product quality and safety.
• Manages audits, deviations, and CAPA activities including root cause analysis.

Skills

Interpersonal communication

Problem solving

FDA regulations

Quality compliance

Root cause analysis

Time management

Education

Bachelor of Science

Equivalency considerations

Job description

Grifols in Rock Hill, SC is seeking a Quality Systems Manager to lead the center's quality management program, implement corrective actions, and ensure compliance with FDA and cGMP requirements.

You will oversee audits, training, document control, and collaboration with the Center Manager to maintain product quality and donor safety. Requires BS and 2 years in a medical/cGMP setting; plasma experience preferred.

We offer benefits and opportunities for growth within a global healthcare company.