Assistant Manager of Quality

CSL•Rialto, CA

1d•$80,100 - $112,200

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 oversees the site Quality Control program, including calibrations, process compliance, competency checks, KPI monitoring and analysis, root-cause assessment, and change management. It leads and develops Quality staff, supports process improvements, and serves as the key quality representative for supplier, customer, and regulatory audits. The position also leads investigations into deviations and audit findings, coordinates corrective and preventive actions (CAPA), and monitors effectiveness checks. It promotes GMP adherence, safety, regulatory compliance, confidentiality, and fair treatment of employees. The role reports quality concerns and significant product-related events to appropriate quality and business leaders. A bachelor's degree in a scientific, life sciences, or related discipline, at least five years of relevant quality and regulatory or plasma-industry experience, demonstrated leadership or supervisory experience, and knowledge of government and industry regulations are specified.

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 or 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; use self-inspection findings, non-conformity discovery, and remediation, and report on center quality 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, develop, and motivate direct reports; ensure they are competent in their QA roles, and, following appropriate review, 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 and education to improve adherence to GMP standards; promptly report concerns or deficiencies and recommend remediation for audit observations and non-compliance.
Serve as the key quality representative for site supplier, customer, and regulatory audits; lead review of findings, coordinate remediation and CAPA as needed, and support timely audit closure.
Maintain a clean, efficient work environment and adequate operating supplies and forms; follow HSE and OSHA policies, conduct routine internal-procedure and documentation audits as necessary, and promote safety.
Follow HR policies and practices, treat employees fairly and equitably, communicate effectively with HR, and help ensure center management complies with HR requirements.
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 notifications to designated senior leaders if necessary.
Maintain confidentiality of personnel, donor, and center information and understand applicable policies for hyperimmune programs.
Lead deviation investigations to determine root causes, corrective and preventive actions, and effectiveness checks; monitor CAPAs and checks to ensure issues are resolved.