Assistant Manager of Quality

CSL Plasma•Kansas City, KS

About The Position

The Assistant Manager of Quality supports quality and regulatory compliance at a CSL Plasma center, ensuring the site remains inspection ready and adheres to Standard Operating Procedures, company policies, and the quality system. The role oversees the center’s Quality Control program, including process monitoring, calibrations, competency checks, KPI analysis, root-cause assessment, and change management. It also leads and develops quality staff, helps improve center processes, and serves as the key quality representative during supplier, customer, and regulatory audits. The position leads investigations into deviations and audit findings, coordinates corrective and preventive actions (CAPA), and monitors effectiveness checks through resolution. It prepares quality reports for center, area, and corporate management; promotes GMP, safety, and regulatory compliance; and escalates events that may negatively affect product safety or quality. The role also maintains confidentiality and supports fair and compliant employee practices.

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; plasma industry experience is specified.
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, using self-inspection findings, non-conformity discovery, and remediation.
Prepare regular reports for center, area, and corporate quality management on the state of quality and center systems.
Manage the site Quality Control program, including calibration management, process compliance monitoring, sampling, competency checks, KPIs, trending and analysis, root-cause and failure-mode impact assessments, and change management.
Lead and develop direct reports, support their competency, and, after appropriate review, recruit and hire staff, conduct performance reviews, and take corrective action up to and including termination.
Work with management to develop programs and methods that streamline processes and improve donor and customer service, product yields, and financial results while maintaining compliance and quality.
Provide staff feedback and education to improve adherence to GMP standards; report concerns or deficiencies promptly and recommend remedial actions.
Lead as the key quality representative for site supplier, customer, and regulatory audits; coordinate review of findings, remediation and CAPA as needed, and timely audit closure.
Use quality tools and applications to support issue understanding and documentation.
Maintain a clean and efficient work environment and adequate operating supplies and forms; comply with HSE and OSHA policies, conduct routine audits of internal procedures and documentation as needed, and promote safety.
Follow HR policies and practices, treat employees fairly and equitably, and communicate with HR to support HR compliance.
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 cause a pause or disruption of business; escalate further when necessary to designated quality or regional leaders.
Maintain confidentiality of personnel, donor, and center information, and understand applicable policies and procedures for hyper immune programs.
Lead deviation investigations to determine root cause, corrections, preventive actions, and effectiveness checks; monitor CAPAs and effectiveness checks through resolution.