Quality & Compliance Lead – Plasma Center

CSL Plasma; Philadelphia (Philadelphia County); On-site; USD 65,000 - 100,000; Full time

Job summary

CSL Plasma is seeking a Quality Assurance professional to monitor plasma center processes for SOP and regulatory compliance. You will collaborate with management to maintain inspection readiness and uphold the quality system across operations.

The role requires 3–5 years in plasma quality with at least 1 year in a supervisory capacity, strong knowledge of cGMP/FDA, and excellent customer service. You will support training, documentation, and internal audits to ensure quality and regulatory

Qualifications

• Bachelor's/Associate in business admin or biological sciences, or equivalent mix of education, experience.
• 3-5 years' experience in quality within Plasma or related industry.
• Minimum 1-year supervisory/leadership experience or equivalent of 1-year experience in a regulated environment.
• Knowledge of cGMP, OHSA, FDA, and other applicable regulations.
• Strong customer service skills.
• Equivalent combination of education and professional work experience required.

Responsibilities

• Monitor plasma center processes to ensure SOPs and local, state, and federal compliance.
• Partner with management to keep the center inspection ready by enforcing the quality system.
• Ensure compliance to quality processes, regulatory requirements, SOPs and training.
• Coordinate training and ensure timely reporting of biologic product deviations to FDA.
• Conduct center records quality reviews for accuracy and timeliness of required information.
• Initiate investigations and develop corrective action plans with management.
• Maintain training materials and Learning Management System data integrity.
• Lead internal audits to monitor facility compliance with SOPs, cGMP, OSHA, FDA, and other regulations.

Skills

Quality assurance

SOP compliance

Regulatory knowledge

Leadership

Documentation

Training

FDA regulations

Customer service

Education

Bachelor's/Associate degree in business administration or biological sciences

Job description

CSL Plasma is seeking a Quality Assurance professional to monitor plasma center processes for SOP and regulatory compliance. You will collaborate with management to maintain inspection readiness and uphold the quality system across operations.

The role requires 3–5 years in plasma quality with at least 1 year in a supervisory capacity, strong knowledge of cGMP/FDA, and excellent customer service. You will support training, documentation, and internal audits to ensure quality and regulatory