Associate Director, Project Quality, Vendor Qualification

CSL; Illinois; On-site; USD 172,000 - 203,000; Full time

Job summary

CSL Behring Kankakee site expansion seeks a Quality Oversight leader to manage external supplier quality for the M7/8 project. You will lead audits, ensure regulatory compliance, and drive end-to-end quality processes for raw materials, services, and distributors.

The role requires senior GxP experience, strong leadership, and collaboration across global teams; you will interface with site operations and regulatory bodies to support safe, compliant manufacturing.

Qualifications

• 10+ years in a GxP environment within the pharmaceutical industry.
• Minimum 3 years leading a team.
• Strong regulatory knowledge (FDA, PIC/s, EU, TGA, Health Canada).
• Experience auditing internal and external suppliers.

Responsibilities

• Implement strategic goals established by functional leadership.
• Collaborate to manage supplier qualification auditing program and auditor qualification standards.
• Establish risk management tools for supplier and raw material monitoring.
• Serve as primary M7/8 site interface for supplier quality issues.
• Attend deviation review meetings and assist deviation investigations.
• Participate in change control processes.
• Perform quality systems audits of suppliers, service providers, and distributors.
• May perform M7/8 project site audits as requested.
• Represent External Supplier Quality policies during regulatory audits.

Skills

Auditing

GxP knowledge

Quality systems auditing

Leadership

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in biology/chemistry/microbiology

Advanced degree preferred

Job description

Job Purpose:

The growing demand 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 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 st CSL Behring Kankakee site.

This role will provide Quality oversight for the external supplier's/vendor's activities associated with the Module 7/8 Site Expansion Project at the CSL Behring Kankakee site.

This position is responsible for ensuring that efficient, compliant, and end-to-end business processes are implemented and maintained for all GxP-related raw material suppliers, service providers, and distributors. The role also leads a small team of auditors responsible for conducting audits of external suppliers and service providers to ensure compliance with applicable regulatory and quality requirements.

Main Responsibilities and Accountabilities:

• Implement strategic goals established by functional leadership.
• Collaborate with External Supply Quality colleagues to manage overall supplier qualification auditing program including establishment of standardized auditor qualification requirements; on-site, remote or paper audit determination.
• Through the identification and utilization of best-in-class practices, establish appropriate risk management tools, supplier and raw material monitoring concepts.
• Serves as primary M7/8 site interface and point of communication of all supplier quality related matters or issues.
• Attends local deviation review meetings and acts as quality liaison between Supplier and Site (M7/8 project scope) to assist deviation investigation processes.
• Participates in change control process as required.
• Performs quality systems audits of approved and/or potential suppliers of raw materials and components, service providers and distributors, for the M7/8 project.
• May also perform M7/8 project site audits, as requested.
• Represents and articulates External Supplier Quality policies and procedures during regulatory audits.

Qualifications:

• Bachelor's degree in relevant scientific discipline (biology, microbiology,chemistry, etc.); advanced degree preferred
• 10+ years' experience in a GxP environment in the pharmaceutical industry. Minimum 3 years' experience in leading a team.
• Thorough understanding of required regulations including but not limited to FDA, PIC/s and European regulation, Therapeutics Goods Administration, Canadian Health Authority, etc.
• Strong industry knowledge (of CSL Behring's process flow and the plasma business), and auditing knowledge (internal and external) experiences within the industry.
• Must be comfortable working in a global, matrix organization.

Competencies:

• Strong organizational skills. Managing diversity, time management and planning. Cross-cultural sensitivity, perseverance, written and verbal communication.
• Demonstrated experience with directing others and delegation.
• Managerial courage, decision quality, functional and technical skills.
• Proficient in building consensus and escalating issues.
• Excellent communication and organizational skills, as well as negotiation, influencing and collaboration skills. Fluent in English (written and spoken).
• Demonstrated ability to work cross-functionally across internal and external stakeholders.
• Effective presentation and meeting skills within all levels of the organization and with external colleagues and collaborators.

The expected base salary range for this position at hiring is $172,000 - $203,000. 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.

About CSL Behring

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 pla