CQV Quality Lead for Ig Fill-Finish GMP Expansion

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

Résumé du poste

CSL Behring is expanding its Kankakee site to support Ig production through M7/8 CQV activities. This role provides quality oversight for commissioning and qualification of the new facility, ensuring GMP-compliant planning, SOP maintenance, and document control.

You will also support inspections, change controls, and CQV document approvals. The ideal candidate has 5+ years in quality/GMP, with strong regulatory knowledge across GxP frameworks and experience in biologics manufacturing.

Qualifications

• 5 years' experience in quality/GMP in the pharmaceutical/biotech industry.
• Demonstrates experience in quality assurance and regulatory compliance.
• with GxP, FDA, TGA, EU, and other regulatory agency guidelines and in manufacturing of biologics.
• Experience in quality oversight of GMP-compliant commissioning and qualification of production facilities, equipment, and cleanrooms.
• Strong quality process knowledge.
• Engineering experience desirable.

Responsabilités

• Ensuring GMP-compliant planning and implementation of M7/8
• Maintains GMP-related quality systems including SOPs and supportive systems to ensure cGMP compliance.
• Reviews and approves standards and procedures governing CQV quality systems and processes. Supports document management, change control, deviation handling, and supplier qualification.
• Supports regulatory inspections, self-inspections and customer audits.
• Supports local & global change requests related to CQV activities
• Reviews and approves all CQV documents including risk assessments, URSs, CQV protocols and reports.

Connaissances

GxP knowledge

Quality assurance

Regulatory compliance

CQV oversight

Interpersonal communication

Formation

Degree in relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)

Description du poste

CSL Behring is expanding its Kankakee site to support Ig production through M7/8 CQV activities. This role provides quality oversight for commissioning and qualification of the new facility, ensuring GMP-compliant planning, SOP maintenance, and document control.

You will also support inspections, change controls, and CQV document approvals. The ideal candidate has 5+ years in quality/GMP, with strong regulatory knowledge across GxP frameworks and experience in biologics manufacturing.