Associate Director, Project Quality QC

The growing demand for expanding production lined requires an expansion of CSLs manufacturing capacity. To support this growth immunoglobulin (Ig) production activitiesfrom plasma thawing through sterile fillingwill 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 change control activities associated with the M 7/8 Site Expansion Project at the CSL Behring Kankakee site.

The Associate Director Quality Control (QC) will provide strategic and operational leadership for Quality Control activities supporting the M7/M8 Immunoglobulin (Ig) Expansion Project. This role is accountable for building and leading a high-performing QC organization that ensures successful project execution regulatory compliance operational readiness method lifecycle management laboratory qualification and commercialization support for expanded manufacturing capacity.

The individual will serve as a key member of the Project Quality leadership team and cross-functional project governance structure. Forming key partnerships with the Site QC and Operational Quality team to ensure delivery of the robust and complaint operational QC laboratory fit to the expansion.

Other partnerships within Manufacturing QC Technical Services Engineering Technical Operations Validation Global Quality Regulatory Affairs and Supply Chain to deliver project milestones while maintaining compliance with cGMP regulatory requirements and company quality standards.

Reports To: Senior Director Project Quality

Direct Reports: QC Analysts QC Sample Management Associate QCAT Associates

Responsibilities:

1. Provide strategic leadership and governance for all M7/8 QC activities supporting the successful delivery startup qualification validation and operational readiness of the new IgG manufacturing facility.

2. Identify assess and mitigate project risks impacting QC deliverables laboratory readiness testing capacity method implementation and qualification timelines escalating critical issues to senior leadership as appropriate.

3. Lead QC activities supporting facility design reviews user requirements laboratory fit-out equipment selection and workflow optimization in consultation with site Operational QC. Develop and execute the overall project strategy ensuring alignment with project objectives regulatory expectations cGMP requirements site priorities and CSL quality standards.

4. Ensure timely readiness of QC activities including utilities and environmental monitoring sampling testing for project qualification activities assay tech transfer and validation equipment purchases and qualification establishment of new raw materials and testing support of qualification runs. to support engineering runs process validation PPQ activities and commercial manufacturing.

5. Develop and execute comprehensive operational readiness plans including staffing training procedures equipment qualification and inventory management.

6. Manage QC activities by project timelines budgets resources and risk mitigation plans to support successful project delivery.

7. Review and assess existing QC policies and procedures for successful execution of M 7/8. Perform gap assessment and suggest improvements in existing and future procedures and policies.

8. Establish and maintain a comprehensive QC project roadmap ensuring milestones resources budgets risks and deliverables are proactively managed and aligned with overall project timelines

9. Provide strategic oversight of change control activities related to analytical methods specifications testing strategies laboratory systems equipment and quality processes ensuring timely implementation to meet project objectives.

10. Build and maintain strong relationships with internal and external stakeholders including regulatory authorities equipment suppliers testing laboratories consultants and project partners as required.

Qualifications:
Bachelors degree in relevant scientific discipline (biology microbiologychemistry etc.); advanced degree preferred
10 years experience in microbiological and biological chemical or biochemical analytics in a pharmaceutical/medicinal GMP environment

Significant experience in laboratory management including operations optimization Strong experience supporting regulatory inspections and customer audits.

Extensive knowledge of analytical instruments and GxP regulations.

Management/demonstrated leadership experience

Experience within a global matrix organization

Six sigma lean and/or variability reduction

Ability to work in a fast-paced environment and balance future needs with immediate pressures

The expected base salary range for this position at hiring is $154000- $193000. 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 addition to base salary total compensation for this role may also include incentive compensation and equity.

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL.

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