Senior Quality Assurance & Compliance Lead

BioSpace; Auburn (AL); On-site; USD 90,000 - 130,000; Full time

Job summary

CSL Plasma is seeking a QA Leader to ensure the center remains inspection-ready by enforcing SOPs, quality systems and regulatory compliance across the center.

You will lead a QA team, manage CAPAs, audits, enhance process efficiency, and drive continuous improvement while maintaining safety and ethics in a highly regulated plasma-donor environment. Strong data-driven reporting and collaboration with corporate quality management are essential to sustain high standards.

Qualifications

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

Responsibilities

• Ensure center is inspection ready by enforcing SOPs, compliance policies and quality system.
• Manage site Quality Control program including calibrations, sampling, KPIs and trend analysis.
• Lead and develop QA staff; recruit, conduct performance reviews and take corrective actions.
• Develop programs to streamline center processes for better service, yields and finances while maintaining quality.
• Provide feedback to staff on GMP adherence; escalate non-compliance and propose corrective actions.
• Lead supplier, customer and regulatory audits; coordinate remediation and close audits on time.
• Maintain clean workplace and ensure supplies; comply with HSE and OSHA policies; promote safety.
• Adhere to HR policies; ensure HR compliance and fair treatment.
• Comply with all regulations; notify appropriate leaders of events affecting safety/quality.
• Lead investigations into deviations; monitor CAPA and effectiveness checks.

Skills

Leadership

Quality/regulatory experience

Regulatory knowledge

Process improvement

Education

Bachelor degree in scientific discipline/life sciences or related discipline

Job description

CSL Plasma is seeking a QA Leader to ensure the center remains inspection-ready by enforcing SOPs, quality systems and regulatory compliance across the center.

You will lead a QA team, manage CAPAs, audits, enhance process efficiency, and drive continuous improvement while maintaining safety and ethics in a highly regulated plasma-donor environment. Strong data-driven reporting and collaboration with corporate quality management are essential to sustain high standards.