Job Purpose:

The growing demand for Privigen and Hizentra 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 45 at the CSL Kankakee (KAN) site to accommodate ZAPP Ig production. The new fill-finish facility is part of the Ig manufacturing expansion, known as Module (M) 7/8 at the CSL Behring Kankakee site.

This role will provide Quality oversight for the Commissioning and Qualification activities (C & Q). Partnering closely with colleagues in Project Quality, KAN Site Quality, Global Engineering, and TechOps across multiple manufacturing sites to ensure consistent application of quality principles, systems, and documentation standards.

The incumbent will focus on driving a standardized approach across projects, ensuring alignment in processes, documentation, and execution.

Responsible for building and maintaining strong collaborative relationships across all levels of the organization and with external contractors.

Responsibilities & Accountabilities:

• Ensure GMP-compliant planning and implementation of validation related project tasks.
• Maintain quality systems including standard operating procedures (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, relevant to C&Q.
• 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/concepts.
• Actively participate in problem solving and identifying opportunities for improvement to optimize validation activities.
• Reviews and approves equipment, utilities, facilities documentation for qualification and validation activities (i.e. Protocols, Reports, Revalidations etc.)
• Reviews and approves validation governance documentation including procedures, templates, project plans, risk assessments and validation master plan for site processes and support with the delivery of global approaches.
• Actively maintain current knowledge relating to equipment qualification and validation activities. Information will be gained through regulatory, industry, and company sources.
• Promote the education and implementation of the relevant regulatory requirements including the FDA, PIC/S, EMA and other industry regulations and guidelines (PDA, ICH etc.)

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 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
• Experience in working in a matrix/global environment
• Engineering experience desirable

Competencies:

• Efficient and risk-based decision-making ability in a quality environment
• Knowledge of GMP, FDA, EU and other relevant GxP regulations
• Ability to influence others through clear, concise and effective communication
• Good organizational and interpersonal skills
• Collaborate effectively with internal and external colleagues and stakeholders
• Experience in project-oriented working methods
• Fluent English skills (spoken and written)

Working Conditions:

• As defined in an office position. Primarily sitting and working on a computer.

Travel Requirements:

• Potential travel required

The expected base salary range for this position at hiring is $91,000 - $120,000. 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