Senior Quality Specialist, Project QA, CQV

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

Job summary

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.

Responsibilities

• 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.

Skills

Communication

Organization

Team collaboration

GxP knowledge

Education

Degree in related 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.

Responsibilities:

• Ensuring GMP-compliant planning and implementation of M7/8
• Maintains GMP-related quality systems including standard operating procedures (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 all regulatory inspections, self-inspections and customer audits.
• Supports local & global change requests related to CQV activities
• Reviews and approves all CQV documents that include but are not limited to risk assessments, URSs, CQV protocols and reports.

Qualifications:

Education

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

Experience

• 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.

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.