Assistant Manager of Quality

CSL•Kansas City, MO

About The Position

The Assistant Manager of Quality oversees quality systems and regulatory compliance at a CSL Plasma center, keeping the center inspection-ready and ensuring adherence to SOPs, compliance policies, and quality principles. The role manages site quality-control activities, including calibration, process monitoring, competency checks, KPI analysis, root-cause assessment, and change management. It also prepares regular quality reports for center, area, and corporate quality management. The position leads and develops QA staff, supports staffing and performance management in coordination with center and quality management, and works with management to improve center processes while maintaining compliance. It leads supplier, customer, and regulatory audits; coordinates remediation and CAPA; investigates deviations; and monitors corrective actions and effectiveness checks. The role also promotes workplace safety, maintains a clean and efficient work environment, ensures availability of supplies and forms, supports HR compliance, and protects confidential personnel, donor, and center information. Significant events affecting product safety or quality must be reported to the appropriate quality leadership.

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 or in the plasma industry.
Demonstrated leadership or supervisory experience.
Knowledge of government and industry regulations.

Responsibilities

Keep the center inspection-ready by managing adherence to SOPs, compliance policies, and the quality system; apply quality principles, self-inspection findings, non-conformity discovery, and remediation.
Prepare regular reports on the state of quality and systems for center, area, and corporate quality management.
Manage the site Quality Control program, including calibrations, process-compliance monitoring, sampling, competency checks, KPIs, KPI trending and analysis, root-cause and failure-mode impact assessment, and change management.
Lead and develop direct reports, ensuring they are competent in their QA roles; educate and motivate staff and, after appropriate review with center and quality management, recruit, hire, conduct performance reviews, and take corrective action up to termination.
Work with management to develop programs and methods that streamline center processes and improve customer and donor service, product yields, and financial results while maintaining compliance and quality.
Provide staff feedback on observations and GMP adherence; report concerns or deficiencies promptly to area personnel or management and recommend remedial actions.
Serve as the key quality representative for site supplier, customer, and regulatory audits; lead reviews of findings, coordinate remediation and CAPA, and support timely audit closure.
Maintain a clean, efficient work environment and ensure operating supplies and forms are available; comply with HSE and OSHA policies, conduct routine internal-procedure and documentation audits as necessary, and promote safety.
Adhere to HR policies and practices, treat employees fairly and equitably, and communicate with HR to support compliance at the center.
Comply with federal, state, and local regulations and company policies and procedures.
Notify the ADOQ of events that negatively affect product safety, quality, identity, purity, or potency and disrupt or pause business; escalate further to designated quality or regional leaders when necessary.
Maintain confidentiality of personnel, donor, and center information and understand applicable hyperimmune-program policies and procedures.
Lead deviation investigations to determine root cause, corrective and preventive actions, and effectiveness checks; monitor CAPAs and effectiveness checks through resolution.