Senior Quality & Compliance Lead

CSL; Loíza (PR); Presencial; USD 80.000 - 110.000; Jornada completa

Descripción de la vacante

CSL is seeking a Quality Assurance leader to ensure the center remains inspection ready by enforcing SOPs, quality systems and regulatory compliance. You will lead the QA team, manage calibration programs, KPIs, CAPA and audits, and partner with management to improve customer service, yields and financial results while maintaining safety and regulatory standards.

You will drive investigations, report findings to corporate quality management, recruit and develop staff, and uphold HR, HSE and OSHA

Formación

• Bachelor’s degree in scientific discipline or life sciences.
• 5+ years’ experience related to quality and regulatory/plasma industry experience.
• Demonstrated leadership/supervisory experience.
• Knowledge of government and industry regulations.

Responsabilidades

• Ensure center is inspection ready by managing SOPs, quality system compliance and remediation.
• Manage site Quality Control program including calibrations, sampling, KPIs, trend analysis and CAPA.
• Lead and develop staff to maintain QA competency; recruit, review performance and take corrective actions.
• Collaborate with management to streamline center processes for improved service, yields and financial results.
• Provide feedback to staff on GMP adherence and report non-conformities promptly.
• Lead audits for supplier, customer and regulatory entities and coordinate CAPA closures.
• Maintain safe, clean work environment and ensure HSE/OSHA compliance.
• Ensure HR policies are followed and center management adheres to HR compliance.
• Notify ADOQ of events affecting safety or product integrity as required.
• Lead investigations into deviations and monitor CAPA effectiveness.

Conocimientos

Leadership / supervisory experience

Regulatory knowledge

Quality systems understanding

Audit coordination

Educación

Bachelor's degree in scientific discipline/life sciences or related discipline

Descripción del empleo

CSL is seeking a Quality Assurance leader to ensure the center remains inspection ready by enforcing SOPs, quality systems and regulatory compliance. You will lead the QA team, manage calibration programs, KPIs, CAPA and audits, and partner with management to improve customer service, yields and financial results while maintaining safety and regulatory standards.

You will drive investigations, report findings to corporate quality management, recruit and develop staff, and uphold HR, HSE and OSHA