Assistant Manager of Quality

CSL Plasma•El Paso, TX

About The Position

The Assistant Manager of Quality oversees quality assurance and quality control at a CSL Plasma center, helping ensure the center remains inspection ready and compliant with Standard Operating Procedures, quality systems, and applicable regulations. The role leads quality activities, staff development, audit response, investigations, and corrective and preventive actions while supporting operational improvements and donor and customer service. The position also maintains a clean and efficient work environment, promotes safety, protects confidential information, and ensures compliance with company and HR policies. The role communicates significant events affecting product safety or quality to appropriate quality leadership. Responsibilities and qualifications may vary based on local legal or educational requirements.

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 specified.
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, using quality principles, self-inspection findings, nonconformity 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 analysis, 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 their development.
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.
Provide staff feedback on observations that can improve adherence to GMP standards, report concerns or deficiencies promptly to area personnel or management, and recommend remedial actions for audit observations and other compliance issues.
Serve as the key quality representative for site supplier, customer, and regulatory audits; lead center review of findings, coordinate remediation and CAPA as needed, and support timely audit closure.
Use quality tools and applications to help understand issues and document them.
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 effectively 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 result in paused or disrupted business; elevate notification to specified quality or regional leaders when necessary.
Maintain confidentiality of personnel, donor, and center information, and understand procedures associated with hyperimmune programs at the center if applicable.
Lead deviation investigations to determine root cause and corrective or preventive actions; monitor CAPAs and effectiveness checks to ensure issues are resolved.