Assistant Manager of Quality

CSL Plasma•Auburn, AL

About The Position

The Assistant Manager of Quality oversees quality systems and regulatory compliance at a CSL Plasma center, ensuring the center remains inspection-ready and that quality practices support safe, compliant operations. The role manages the site Quality Control program, including calibrations, process compliance monitoring, competency checks, KPI analysis, root-cause and failure-mode assessments, and change management. The position leads and develops QA staff, collaborates with center management to improve processes and service outcomes, and serves as the center’s key quality representative during supplier, customer, and regulatory audits. It also leads investigations and CAPA activities, reports quality concerns, and escalates events that may negatively affect product safety or quality. The role requires adherence to applicable regulatory, company, health, safety, environmental, and HR policies, as well as maintaining confidentiality of personnel, donor, and center information.

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 also cited.
Demonstrated leadership or supervisory experience.
Knowledge of government and industry regulations.

Responsibilities

Ensure the center is inspection-ready by managing adherence to SOPs, compliance policies, and the quality system, and by applying quality principles, self-inspection learnings, non-conformity findings, and appropriate 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 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, ensure they are competent in their QA roles, and motivate staff through education and example.
After appropriate review with center and quality management, recruit and hire staff, conduct performance reviews, and enact corrective actions up to and including 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.
Give staff feedback on observations to improve adherence to GMP standards and promptly report concerns or deficiencies to area personnel or management.
Recommend remedial actions to resolve audit observations and other non-compliance issues or deficiencies.
Lead and serve as the key quality representative for site supplier, customer, and regulatory audits; coordinate review of findings and remediation (CAPA), as needed, and support timely audit closure.
Use quality tools and applications to support understanding of issues and documentation.
Maintain a clean, efficient work environment and ensure operating supplies and forms are available as needed.
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 through fair and equitable employee treatment, communicate with HR to ensure compliance, and ensure center management does the same.
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 result in a business pause or disruption; elevate notification to specified regional or quality leaders if necessary.
Maintain confidentiality of personnel, donor, and center information, and understand policies and procedures for hyper immune programs at the center if applicable.
Lead deviation investigations to determine root cause, corrections, preventive actions, and effectiveness checks; monitor CAPAs and checks to ensure issues are resolved.