Assistant Manager of Quality (Bilingual – English/Spanish)

CSL•Americas, US-PR, Loiza 004, CSL Plasma, PR

13d

About The Position

The Assistant Manager of Quality oversees quality systems and regulatory compliance at a center, maintaining inspection readiness and supporting safe, compliant, efficient operations. The role manages the site Quality Control program, prepares quality reports, and leads audits, investigations, and corrective and preventive actions (CAPA). It also develops and supervises quality staff and collaborates with center management to improve processes, customer and donor service, product yields, and financial results while maintaining quality and compliance. The position requires English and Spanish bilingual ability as indicated in the job title. Local legal or educational requirements may result in different qualifications or responsibilities; local job documentation should be consulted where applicable.

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 and/or plasma industry experience.
Demonstrated leadership or supervisory experience.
Knowledge of government and industry regulations.
Bilingual in English and Spanish, as indicated by the job title.

Responsibilities

Maintain the center’s inspection readiness by managing adherence to SOPs, compliance policies, and the quality system, using self-inspection findings, nonconformity discovery, and remediation.
Prepare regular reports for center, area, and corporate quality management on the state of quality and systems at the center.
Manage the site Quality Control program, including calibrations, monitoring compliance with defined processes, sampling, competency checks, KPIs, KPI trending and analysis, root-cause and failure-mode impact assessments, and change management.
Lead and develop direct reports, ensuring they are competent to perform their quality assurance roles; motivate staff through education and development.
With appropriate review by 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 and report concerns or deficiencies promptly to area personnel or management.
Recommend remedial actions to address audit observations and other noncompliance issues or deficiencies.
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 support understanding and documentation of issues.
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 effectively with HR to ensure compliance, and ensure center management does the same.
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 to other specified quality or regional leaders if necessary.
Maintain confidentiality of personnel, donor, and center information and understand applicable policies and procedures for hyper-immune programs.
Lead deviation investigations to determine root cause, corrections, preventive actions, and effectiveness checks; monitor CAPAs and effectiveness checks to confirm issues are resolved.