Senior Quality Validation Project Manager

CSL; Kankakee (IL); On-site; USD 91,000 - 120,000; Full time

Job summary

CSL Behring in Kankakee, IL, is expanding its Ig manufacturing module. This role provides Quality oversight for commissioning and qualification activities, partnering with Project Quality, KAN Site Quality, Global Engineering, and TechOps to ensure consistent application of quality principles and documentation.

You will drive standardized processes across projects, maintain quality systems, and support regulatory inspections.

Qualifications

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

Responsibilities

• Ensure GMP-compliant planning and implementation of validation related tasks.
• Maintain quality systems including SOPs and supportive systems to ensure cGMP compliance.
• Review and approve standards and procedures governing quality systems and processes; supports document management, change control, deviation handling.
• Support all regulatory inspections, self-inspections, internal audits and customer audits.
• Collaborate cross-functionally and communicate best practices.
• Provide Quality Oversight of the GMP-compliant realization of CAPEX and OPEX projects.
• Provide technical advice on qualification and validation issues.
• Promote education and implementation of relevant regulatory requirements (FDA, PIC/S, EMA).

Skills

Quality oversight

GMP knowledge

Validation

Change control

Documentation

Regulatory inspections

Cross-functional

Project management

English fluency

Education

Bachelor or higher in Pharmacy, Chemistry, Biology, Biochemistry

Job description

CSL Behring in Kankakee, IL, is expanding its Ig manufacturing module. This role provides Quality oversight for commissioning and qualification activities, partnering with Project Quality, KAN Site Quality, Global Engineering, and TechOps to ensure consistent application of quality principles and documentation.

You will drive standardized processes across projects, maintain quality systems, and support regulatory inspections.