Quality Assurance Lead — Center Operations

CSL Plasma Inc.; Auburn (AL); Hybrid; USD 95,000 - 145,000; Full time

Job summary

CSL Plasma is seeking a seasoned QA leader to ensure the center remains inspection-ready by enforcing SOPs, quality policies, and the broader quality system, with careful attention to non-conformities and remediation. This role will drive CAPA processes, audit readiness, and continuous quality improvement across the center, while mentoring staff to higher levels of competency.

The ideal candidate has a strong background in GMP, quality systems, and regulatory expectations, with proven

Qualifications

• Extensive experience in quality and regulatory systems in plasma/biopharma.
• Proven leadership with ability to develop staff and drive corrective actions.
• Strong knowledge of GMP, CAPA, deviation investigations, and audits.

Responsibilities

• Ensure center is inspection-ready by enforcing SOPs and quality systems.
• Maintain and monitor the Quality Control program including KPIs and trends.
• Lead and develop QA staff, conduct performance reviews and corrective actions.
• Lead supplier, customer, and regulatory audits and CAPA closure.
• Maintain health, safety, and environmental compliance and HR policies adherence.

Skills

Quality management

Regulatory knowledge

Leadership & mentoring

GMP/compliance

Education

Bachelor's degree in life sciences or related discipline

Job description

CSL Plasma is seeking a seasoned QA leader to ensure the center remains inspection-ready by enforcing SOPs, quality policies, and the broader quality system, with careful attention to non-conformities and remediation. This role will drive CAPA processes, audit readiness, and continuous quality improvement across the center, while mentoring staff to higher levels of competency.

The ideal candidate has a strong background in GMP, quality systems, and regulatory expectations, with proven