Plasma Center Quality Assurance Leader

Kedplasma-LLC; Patton Park (NC); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Health benefits

Paid time off

Career growth

Training programs

Employee discounts

Job summary

Kedrion Biopharma Inc. is seeking a Center Quality Manager to lead quality operations at our plasma center, ensuring FDA/EU compliance and regulatory readiness. You will manage audits, investigations, and staff development, with the authority to stop production when donor safety or product quality is at risk.

You will collaborate with the Center Manager to maintain documentation, training, product release, and continuous improvement across quality activities.

Qualifications

• Bachelor’s degree in healthcare, life sciences, or related field preferred.
• 3-5 years of experience in plasma or biomedical field.
• Minimum 1 year in a regulated industry; cGMP experience preferred.
• Strong understanding of FDA and EU regulations.
• Excellent organizational, analytical, and documentation skills.
• Willingness to travel to other Kedrion centers as needed.

Responsibilities

• Oversee all quality operations at the plasma center and ensure SOP compliance.
• Lead audits, investigations, and corrective actions to maintain regulatory readiness.
• Review plasma collection records and documentation for accuracy.
• Oversee plasma release, shipments, and verification of specifications.
• Lead CLIA proficiency testing, complaint investigations, and certification tracking.
• Collaborate with leadership to foster continuous quality improvement.

Skills

Quality leadership

Regulatory compliance

Audit management

Documentation

Team leadership

Data analysis

Education

Bachelor's degree in healthcare

Tools

Microsoft Office

Job description

Kedrion Biopharma Inc. is seeking a Center Quality Manager to lead quality operations at our plasma center, ensuring FDA/EU compliance and regulatory readiness. You will manage audits, investigations, and staff development, with the authority to stop production when donor safety or product quality is at risk.

You will collaborate with the Center Manager to maintain documentation, training, product release, and continuous improvement across quality activities.