Assistant Manager of Quality

CSL Plasma•Waukegan, IL

About The Position

The Assistant Manager of Quality is responsible for maintaining the center’s inspection readiness and quality systems, ensuring adherence to Standard Operating Procedures, compliance policies, and applicable quality principles. The role manages the site Quality Control program, including calibrations, process compliance monitoring, competency checks, KPI trending and analysis, root-cause assessment, and change management. The position also leads and develops quality staff and serves as the key quality representative for supplier, customer, and regulatory audits. The Assistant Manager works with center management to improve processes, customer and donor service, product yields, and financial results while maintaining compliance and quality. The role leads investigations into deviations, coordinates corrective and preventive actions, monitors effectiveness checks, and escalates significant events that may affect product safety or quality. It also supports safety, HR compliance, regulatory compliance, and the maintenance of a clean and adequately supplied work environment. CSL Plasma operates a plasma donation network, and plasma collected at its facilities is used by CSL to manufacture plasma-derived therapies. CSL Plasma is a subsidiary of CSL, a global biopharmaceutical company. CSL states that inclusion and belonging are central to its mission and that it is an Equal Opportunity Employer.

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

Maintain center inspection readiness by managing adherence to SOPs, compliance policies, and the quality system, applying quality principles and addressing self-inspection findings and non-conformities.
Prepare regular reports for center, area, and corporate quality management on the center’s quality status and systems.
Manage the site Quality Control program, including calibrations, process compliance, sampling, competency checks, KPIs, KPI trending and analysis, root-cause and failure-mode impact assessments, and change management.
Lead and develop direct reports, build staff competency, and, following appropriate review, recruit and hire staff, conduct performance reviews, and implement corrective actions up to and including termination.
Work with management to develop programs and methods that improve center processes, customer and donor service, product yields, and financial results while maintaining compliance and quality.
Provide staff feedback and education to improve adherence to GMP standards, promptly report concerns or deficiencies, and 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 reviews of findings, coordinate remediation and CAPA where needed, and support timely audit closure.
Use quality tools and applications to support understanding and documentation of issues.
Maintain a clean, efficient work environment and ensure operating supplies and forms are available.
Comply with HSE and OSHA policies and procedures, conduct routine audits of internal procedures and documentation as necessary, and promote safety.
Follow HR policies and practices, treat employees fairly and equitably, communicate with HR to support compliance, and ensure center management does likewise.
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 business to pause or be disrupted; escalate further to designated regional or quality leaders when necessary.
Maintain confidentiality of personnel, donor, and center information, and understand policies and procedures for applicable hyper immune programs.
Lead deviation investigations to identify root causes, determine corrective and preventive actions, and conduct effectiveness checks; monitor CAPAs and checks to ensure issues are resolved.