Assistant Manager of Quality

CSL•Waukegan, IL

About The Position

The Assistant Manager of Quality manages quality systems and regulatory compliance at a CSL Plasma center, keeping the center inspection-ready and supporting safe, compliant plasma collection. The role oversees the site Quality Control program, including calibrations, process compliance, competency checks, KPIs, trend analysis, root-cause assessment, and change management. It also prepares regular quality reports for center, area, and corporate management. The position leads and develops quality staff, supports recruitment and performance management, and works with center management to improve processes, customer and donor service, product yields, and financial results while maintaining compliance. The Assistant Manager of Quality serves as the key site quality representative during supplier, customer, and regulatory audits; coordinates investigations and CAPA remediation; and monitors corrective actions through effectiveness checks and closure. The role also promotes safety, maintains a clean and efficient work environment, upholds HR and confidentiality policies, and escalates events that may negatively affect product safety or quality.

Requirements

Bachelor’s degree in a scientific discipline, life sciences, or a related discipline.
At least 5 years of experience related to quality and regulatory work and/or plasma industry experience.
Demonstrated leadership or supervisory experience.
Knowledge of government and industry regulations.
Different qualifications or responsibilities may apply based on local legal or educational requirements; refer to local job documentation where applicable.

Responsibilities

Keep the center inspection-ready by managing adherence to SOPs, compliance policies, the quality system, and remediation of findings.
Prepare regular reports on the center’s quality and systems for center, area, and corporate quality management.
Manage the site Quality Control program, including calibration management, process monitoring, competency checks, KPIs, trend analysis, root-cause and failure-mode impact assessment, and change management.
Lead, develop, educate, and motivate direct reports; ensure they are competent in their QA roles.
In coordination with center and quality management, recruit and hire staff, conduct performance reviews, and take corrective action up to and including termination.
Work with management to streamline center processes and improve customer and donor service, product yields, and financial results while maintaining quality and compliance.
Provide staff feedback and report concerns or deficiencies; recommend remedial actions for audit observations and other non-compliance issues.
Serve as the key quality representative for site supplier, customer, and regulatory audits; lead review of findings, coordinate CAPA remediation, and support timely audit closure.
Use quality tools and applications to support issue understanding and documentation.
Maintain a clean, efficient work environment and sufficient operating supplies and forms; comply with HSE and OSHA policies, conduct routine audits as needed, and promote safety.
Follow HR policies and equitable treatment practices; communicate with HR to support HR compliance and ensure center management does the same.
Comply with federal, state, local, and company policies and procedures.
Notify the ADOQ of events negatively affecting product safety, quality, identity, purity, or potency that pause or disrupt business, and elevate notifications when necessary to designated quality and regional leaders.
Maintain confidentiality of personnel, donor, and center information; understand applicable hyper immune program policies and procedures.
Lead deviation investigations to determine root cause and corrective and preventive actions; monitor CAPAs and effectiveness checks through resolution.