Assistant Manager of Quality

CSL•Auburn, AL

About The Position

The Assistant Manager of Quality ensures the center remains inspection-ready by managing adherence to Standard Operating Procedures, compliance policies, and the quality system. The role applies quality principles, self-inspection findings, non-conformity discovery, and remediation, and prepares regular reports for center, area, and corporate quality management. The position manages the site Quality Control program, including calibrations, compliance monitoring, sampling, competency checks, KPI trending and analysis, root-cause and failure-mode assessments, and change management. It leads and develops direct reports, supports staffing and performance management, and works with management to improve center processes while maintaining compliance and quality. The Assistant Manager of Quality serves as the site's key quality representative for supplier, customer, and regulatory audits; leads investigations and CAPA activities; and ensures timely resolution of findings. The role also supports workplace safety, HR and regulatory compliance, accurate documentation, confidentiality, and required escalation of events that may 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 matters 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 learnings, non-conformity discovery, and remediation.
Prepare regular reports on the center's quality and systems for center, area, and corporate quality management.
Manage the site Quality Control program, including calibrations, process-compliance monitoring, sampling, competency checks, KPI monitoring and analysis, trending, root-cause and failure-mode impact assessment, and change management.
Lead and develop direct reports, ensuring they are competent to perform their QA roles; motivate staff through education and support high competency in a regulated environment.
After appropriate review 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 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 that can improve adherence to GMP standards; promptly report concerns or deficiencies to area personnel or management and recommend remedial actions.
Serve as the key site quality representative for supplier, customer, and regulatory audits; lead review of findings, coordinate remediation including CAPA where 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.
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, and communicate with HR to support HR 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 result in paused or disrupted business; escalate further to designated quality or regional leaders when necessary.
Maintain confidentiality of personnel, donor, and center information; understand applicable policies and procedures for hyper immune programs.
Lead deviation investigations to determine root cause, corrective and preventive actions, and effectiveness checks; monitor CAPAs and effectiveness checks through resolution.