Center Quality Leader: Compliance, QA & Training

Octapharma Plasma, Inc.; Louisville (KY); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Health insurance

401k retirement plan

Paid time off

Tuition reimbursement

EAP

Job summary

Octapharma Plasma, Inc. is seeking a Center Quality Manager I in Louisville, KY to lead quality assurance activities at the donation center. You will operate independently from center operations to ensure compliance with FDA/ EMA standards and donor safety.

The role includes overseeing QC, CAPAs, audits, and training staff on GMP, SOPs, and regulatory requirements, with a focus on continuous improvement and regulatory readiness.

Qualifications

• B.S. degree preferred.
• One year of experience in a Quality Assurance role is required.
• Experience with quality management systems (QMS) and quality control processes is preferred.

Responsibilities

• Operate independent of plasma center operations to ensure regulatory compliance.
• Maintain knowledge of regulations affecting donor safety and product quality.
• Lead audits and inspections and prepare audit responses.
• Train QA staff and backup personnel on GMP, SOPs and compliance.
• Oversee QC checks, deviations, CAPAs and complaint handling.
• Ensure readiness of QA processes for shipments and documentation.

Skills

QA experience

GMP knowledge

SOP familiarity

Regulatory compliance

Education

B.S. degree preferred

Job description

Octapharma Plasma, Inc. is seeking a Center Quality Manager I in Louisville, KY to lead quality assurance activities at the donation center. You will operate independently from center operations to ensure compliance with FDA/ EMA standards and donor safety.

The role includes overseeing QC, CAPAs, audits, and training staff on GMP, SOPs, and regulatory requirements, with a focus on continuous improvement and regulatory readiness.