Senior Quality Specialist, Project Quality, CSV

CSL Vifor; Bradley (IL); On-site; USD 76,000 - 95,000; Full time

Job summary

CSL Vifor is expanding Ig production at the Kankakee site to support a new fill-finish facility (M7/8). The role provides Quality oversight for Commissioning and Qualification activities related to the M7/8 Site Expansion, coordinating with Technical Operations, IT, and Global Engineering to ensure global process alignment and documentation standards.

The position requires 5+ years in Quality, IT or Validation, with knowledge of GxP and CFR21 Part 11/Annex 11.

Qualifications

• 5+ years' experience in Quality, IT or Validation.
• Pharma/Biotech or similarly regulated environment experience desirable.
• Knowledge of GxP, FDA and EMA requirements CFR21 Part11 and Annex 11.

Responsibilities

• Ensuring GMP-compliant planning and implementation of M7/8 for CSV.
• Maintains GMP-related quality systems including SOPs and supportive systems for cGMP compliance.
• Reviews and approves standards and procedures governing CSV, quality systems and processes; supports document management, change control, deviation handling, and supplier qualification.
• Supports regulatory inspections, self-inspections and customer audits.
• Ensures IT/ExS procedures and tools integrate with CSV requirements.
• Reviews and approves all CSV documents including risk assessments, URSs, protocols and reports.
• Provides QA oversight and approval of project and operational changes, deviations and investigations involving GxP Computerized Systems, including CAPA plans.

Education

Degree in relevant scientific discipline

Job description

The growing demand for an expanding production line requires an expansion of CSL's manufacturing capacity. To support this growth, immunoglobulin (Ig) production activities—from plasma thawing through sterile filling—will be incorporated into the new Building under construction at the CSL Kankakee (KAN) site to accommodate Ig production. The new fill-finish facility is part of the Ig manufacturing expansion, known as Module (M) 7/8.

This role will provide Quality oversight for the Commissioning and Qualification activities associated with the M 7/8 Site Expansion Project at the CSL Behring Kankakee site for computerized systems.

The position partners closely with colleagues in Technical Operations, IT, and Global Engineering for Ig expansion project (M7/8) to ensure consistent application of quality principles, systems, and documentation standards. A key responsibility is to ensure alignment globally in processes, documentation, and execution.

RESPONSIBILITIES

• Ensuring GMP-compliant planning and implementation of M7/8 for CSV.
• Maintains GMP-related quality systems including standard operating procedures (SOPs) and supportive systems to ensure cGMP compliance.
• Reviews and approves standards and procedures governing CSV, quality systems and processes. Supports document management, change control, deviation handling, and supplier qualification.
• Supports all regulatory inspections, self-inspections and customer audits.
• Ensures IT/ExS procedures and tools accurately integrate and align with computerized system validation (CSV) requirements.
• Reviews and approves all CSV documents that include but are not limited to risk assessments, URSs, protocols and reports.
• Provides QA oversight and approval of project and operational changes, deviations and investigations involving GxP Computerized Systems, including approval of CAPA plans and subsequent tracking of implementation aligned actions.

QUALIFICATIONS

Education

• Degree in relevant scientific discipline, or related (Pharmacy, Chemistry, Biology, Biochemistry).

Experience

• 5+ years' experience in Quality, IT or Validation.
• Pharma/Biotech or similarly regulated environment experience desirable.
• Experience in Quality Assurance, IT, Quality Control, Validation, Production, or Regulatory Affairs.
• Knowledge of GxP, GAMP, FDA and EMA requirements specifically CFR21 part11 and Annex 11.

Competencies

• Knowledge of GMP, FDA, EU and other relevant GxP regulations.
• Effective communication skills.
• Good organizational and interpersonal skills.
• Collaborate effectively with internal and external employees and stakeholders.

The expected base salary range for this position at hiring is $76,000- $95,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.