Quality Assurance Lead — GMP, Audits & CAPA

CSL Vifor; East York (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

CSL Vifor is seeking a Quality Assurance Manager to ensure inspection readiness and lead QA activities within a regulated plasma quality environment. You will drive GMP-compliant practices, lead audits, CAPA programs and continuous improvement while mentoring a team of QA professionals.

You will partner with site management to maintain compliance, manage KPIs, and coordinate with HR and regulatory bodies to uphold safety, identity, and potency standards across the center.

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” at all times by managing adherence to SOPs, compliance policies and the quality system, utilizing sound Quality principles, self-inspection learnings, non-conformity discovery and appropriate remediation.
• Prepare regular reports to center, area and corporate quality management as to the state of quality and systems at the center.
• Manage site Quality Control program including calibrations management, monitoring of compliance to defined processes e.g. sampling, competency checks, KPIs, trending and analysis of KPIs, root cause and failure mode impact assessment and change management.
• Lead and develop direct reports ensuring they are competently skilled to perform their QA roles; recruit, hire, conduct performance reviews and enact corrective actions, up to and including termination.
• Lead center review of findings, coordination of remediation (CAPA), if needed and successful closure of timely audits.
• Adhere to all HR policies and practices through fair and equitable treatment of all employees.
• Comply with all federal, state and local regulatory and company policies and procedures.
• Lead investigations into deviations to determine root cause, correction/preventative actions and effectiveness checks.

Skills

Quality management

Leadership

Regulatory compliance

SOP adherence

Auditing

Education

Bachelor degree in scientific discipline

Tools

CAPA system

KPI tracking

Quality management software

Job description

CSL Vifor is seeking a Quality Assurance Manager to ensure inspection readiness and lead QA activities within a regulated plasma quality environment. You will drive GMP-compliant practices, lead audits, CAPA programs and continuous improvement while mentoring a team of QA professionals.

You will partner with site management to maintain compliance, manage KPIs, and coordinate with HR and regulatory bodies to uphold safety, identity, and potency standards across the center.