QA CQV Lead - GMP Biologics, Site Expansion (Equity)

CSL; Bradley (IL); Sur place; USD 76 000 - 95 000; Plein temps

Résumé du poste

CSL Behring is expanding its Kankakee (KAN) site to support Ig production. This role provides quality oversight for the Commissioning and Qualification activities for the M7/8 site expansion, ensuring GMP-compliant planning and execution throughout all CQV phases.

The role requires a degree in a related scientific discipline and at least 5 years in quality/GMP, with strong knowledge of FDA/EU/GxP guidelines and experience in CQV of production facilities and cleanrooms.

Qualifications

• 5 years' experience in quality/GMP in the pharmaceutical/biotech industry.
• Demonstrates experience in quality assurance and regulatory compliance.
• Knowledge of GMP, FDA, EU and other GxP guidelines.
• Experience in commissioning and qualification of GMP facilities and CQV activities.

Responsabilités

• Provide quality oversight for CQV activities for the M7/8 site expansion.
• Maintain GMP-related quality systems including SOPs and supporting systems.
• Review and approve CQV documents (risk assessments, URSs, protocols, reports).
• Support regulatory inspections, self-inspections, and customer audits.
• Support local and global change requests related to CQV activities.
• Coordinate reviews and approvals of CQV-related documentation.

Connaissances

Communication

Organization

Team collaboration

GxP knowledge

Formation

Degree in related scientific discipline

Description du poste

CSL Behring is expanding its Kankakee (KAN) site to support Ig production. This role provides quality oversight for the Commissioning and Qualification activities for the M7/8 site expansion, ensuring GMP-compliant planning and execution throughout all CQV phases.

The role requires a degree in a related scientific discipline and at least 5 years in quality/GMP, with strong knowledge of FDA/EU/GxP guidelines and experience in CQV of production facilities and cleanrooms.