Assistant Manager of Quality (Bilingual – English/Spanish)

CSL•San Juan, PR

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 identification, and remediation, and prepares regular reports on the state of quality and systems for center, area, and corporate quality management. The position manages the site Quality Control program, including calibration management, process-compliance monitoring, sampling, competency checks, KPI trending and analysis, root-cause and failure-mode impact assessments, and change management. It leads and develops direct reports, building their skills and competency to perform QA duties. In coordination with center and quality management, the role may recruit and hire staff, conduct performance reviews, and take corrective action up to and including termination. The Assistant Manager of Quality works with management to improve center processes while maintaining compliance and quality, provides staff feedback on GMP adherence, and reports concerns or deficiencies to area personnel or management. The role is the key quality representative for site supplier, customer, and regulatory audits; it leads review of findings, coordinates remediation and CAPA when needed, and supports timely audit closure. It also leads deviation investigations, determines root causes and corrective or preventive actions, and monitors CAPAs and effectiveness checks. Additional duties include maintaining an orderly work environment and adequate supplies and forms; complying with HSE, OSHA, HR, regulatory, and company policies; conducting routine internal procedure and documentation audits; promoting safety; maintaining confidentiality of personnel, donor, and center information; and notifying the appropriate quality leaders of events that negatively affect product safety, quality, identity, purity, or potency and disrupt business. Knowledge of policies and procedures associated with hyperimmune programs is required where applicable. The position is bilingual in English and Spanish.

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 specified.
Demonstrated leadership or supervisory experience.
Knowledge of government and industry regulations.
Bilingual in English and Spanish.

Responsibilities

Keep the center inspection-ready by managing adherence to SOPs, compliance policies, and the quality system; use self-inspection findings, identify non-conformities, and oversee remediation.
Prepare regular reports on center quality and systems for center, area, and corporate quality management.
Manage the site Quality Control program, including calibrations, process compliance, sampling, competency checks, KPI trending and analysis, root-cause and failure-mode impact assessments, and change management.
Lead, develop, and motivate direct reports through education and competency development; participate in recruiting and hiring, conduct performance reviews, and enact corrective actions up to and including termination after appropriate review.
Work with management to develop programs and methods that improve center processes, customer and donor service, product yields, and financial results while maintaining compliance and quality.
Provide staff feedback on observations related to GMP adherence and promptly report concerns or deficiencies to area personnel or management; recommend remedial actions for audit observations and other compliance issues.
Serve as the key quality representative for site supplier, customer, and regulatory audits; lead reviews of findings, coordinate CAPA remediation when needed, and support timely audit closure.
Maintain a clean, efficient work environment and ensure operating supplies and forms are available.
Comply with HSE, OSHA, HR, regulatory, and company policies and procedures; conduct routine audits of internal procedures and documentation and promote safety.
Communicate effectively with HR to support HR compliance and ensure center management does the same; treat employees fairly and equitably.
Notify the ADOQ of events negatively affecting product safety, quality, identity, purity, or potency that pause or disrupt business, escalating to the specified quality or regional leaders if necessary.
Maintain confidentiality of personnel, donor, and center information; understand applicable hyperimmune-program policies and procedures.
Lead deviation investigations to determine root cause, corrections, preventive actions, and effectiveness checks; monitor CAPAs and effectiveness checks through resolution.