Plasma Center Operations Leader - Compliance & Care

Kedrion Biopharma GmbH; Gainesville (FL); On-site; USD 60,000 - 80,000; Full time

Job summary

Kedrion Biopharma Inc. is seeking an Assistant Manager for our Gainesville plasma collection center. You will support the Center Manager in daily operations, ensure compliance with SOPs and regulatory requirements, and drive donor satisfaction and team performance.

In this role you’ll oversee staffing, scheduling, equipment oversight, and regulatory compliance, while promoting safety and quality. Prior supervisory experience in a regulated environment is preferred; vaccination and background

Qualifications

• Bachelor’s degree in healthcare, life sciences, business administration, or related field.
• Minimum 1 year of supervisory or management experience, ideally in a plasma or regulated environment.
• Knowledge of plasma operations, FDA, CLIA, and cGMP regulations preferred.
• Strong organizational and leadership skills.
• Proficiency in Microsoft Office and data entry systems.

Responsibilities

• Promote professional customer service and donor retention through staff coaching and support.
• Ensure all center activities comply with SOPs, FDA, EMEA, and customer specifications.
• Maintain operational efficiency and fiscal responsibility in accordance with cGMP and QAP standards.
• Support special donor programs, including titer testing and antibody identification.
• Oversee completion of daily logs and records, including temperature checks and quality control.
• Collaborate with management to ensure appropriate staffing and coverage for donation volumes.
• Maintain accurate personnel records, including evaluations, training, and attendance.
• Assist in scheduling and preparing for staff changes, vacations, and absenteeism.
• Identify and address quality or compliance issues proactively.
• Monitor inventory levels and ensure adequate stock for production needs.
• Manage equipment maintenance schedules and resolve equipment issues promptly.
• Respond to freezer alarms and resolve excursions to protect product quality.
• Participate in deviation management, including documentation, investigations, and CAPA implementation.
• Perform opening and closing duties, including equipment checks, documentation, security protocols, etc.

Skills

Leadership

Organizational skills

Regulatory mindset

Education

Bachelor’s degree in healthcare, life sciences, business administration, or related field

Tools

Microsoft Office

Job description

Kedrion Biopharma Inc. is seeking an Assistant Manager for our Gainesville plasma collection center. You will support the Center Manager in daily operations, ensure compliance with SOPs and regulatory requirements, and drive donor satisfaction and team performance.

In this role you’ll oversee staffing, scheduling, equipment oversight, and regulatory compliance, while promoting safety and quality. Prior supervisory experience in a regulated environment is preferred; vaccination and background