Assistant Manager of Quality

CSL•El Paso, TX

22h

About The Position

The Assistant Manager of Quality oversees quality systems and compliance at a CSL Plasma center, ensuring the center remains inspection-ready and operates according to Standard Operating Procedures, quality principles, and applicable regulations. The role manages the center’s Quality Control program, prepares quality reports, and uses quality tools to assess performance, investigate issues, and drive remediation. The position leads and develops quality staff, supports center process improvements, and serves as the key quality representative during supplier, customer, and regulatory audits. It also oversees investigations and corrective and preventive actions, promotes workplace safety, maintains confidentiality, and ensures compliance with company and regulatory policies. The role requires a bachelor’s degree in a scientific, life sciences, or related discipline, at least five years of related quality and regulatory experience, leadership or supervisory experience, and knowledge of government and industry regulations. Plasma industry experience is also listed among the qualifications.

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.
Different qualifications or responsibilities may apply based on local legal or educational requirements; refer to local job documentation where applicable.

Responsibilities

Ensure the center is inspection-ready by managing adherence to SOPs, compliance policies, and the quality system; use self-inspection findings and non-conformity remediation to maintain quality.
Prepare regular reports for center, area, and corporate quality management on the state of quality and quality systems.
Manage the site Quality Control program, including calibrations, process compliance monitoring, competency checks, KPIs, KPI trending and analysis, root-cause and failure-mode impact assessments, and change management.
Lead and develop direct reports, ensure they are competent in their QA roles, and motivate staff through education. In coordination 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 for audit observations and other compliance issues.
Lead the site’s quality representation during supplier, customer, and regulatory audits; coordinate review of findings and remediation, including CAPA when needed, and support timely audit closure.
Use quality tools and applications to support issue understanding 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, treat employees fairly and equitably, communicate with HR to support compliance, and ensure center management does the same.
Comply with applicable 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 pause or disruption of business; escalate notifications to specified quality or regional leaders when necessary.
Maintain confidentiality of personnel, donor, and center information, and understand applicable policies and procedures for hyperimmune programs.
Lead deviation investigations to determine root causes and corrective and preventive actions, perform effectiveness checks, and monitor CAPAs and checks through resolution.