Associate Director, Project Quality, Vendor Qualification

CSL•Kankakee, IL

4d•$172,000 - $203,000

About The Position

The Associate Director, Project Quality, Vendor Qualification provides Quality oversight for external supplier and vendor activities associated with the Module 7/8 Site Expansion Project at CSL Behring’s Kankakee site. The expansion incorporates immunoglobulin production activities, from plasma thawing through sterile filling, into a new fill-finish facility. The role ensures efficient, compliant, end-to-end business processes for GxP-related raw material suppliers, service providers, and distributors. It also leads a small team of auditors who assess external suppliers and service providers for compliance with applicable regulatory and quality requirements. The position serves as the primary M7/8 site contact for supplier quality matters and works with internal functions and external partners to support supplier qualification, audit, deviation, change control, agreement, and budget processes.

Requirements

Bachelor’s degree in a relevant scientific discipline, such as biology, microbiology, or chemistry.
At least 10 years of experience in a GxP environment in the pharmaceutical industry.
At least 3 years of experience leading a team.
Thorough understanding of applicable regulations, including FDA, PIC/S, European regulations, the Therapeutic Goods Administration, and Canadian health authority requirements.
Strong industry knowledge, including CSL Behring’s process flow and the plasma business, and experience with internal and external auditing in the industry.
Comfort working in a global, matrix organization.
Strong organizational skills, including time management and planning.
Cross-cultural sensitivity and perseverance.
Strong written and verbal communication skills; fluency in English is required.
Demonstrated experience directing others and delegating.
Managerial courage, decision quality, and functional and technical skills.
Proficiency in building consensus and escalating issues.
Negotiation, influencing, and collaboration skills.
Ability to work cross-functionally with internal and external stakeholders.
Effective presentation and meeting skills with colleagues and collaborators at all organizational levels.

Nice To Haves

Advanced degree preferred.

Responsibilities

Implement strategic goals established by functional leadership.
Collaborate with External Supply Quality colleagues to manage the supplier qualification auditing program, including standardized auditor qualification requirements and decisions about on-site, remote, or paper audits.
Establish risk management tools and supplier and raw material monitoring concepts using best practices.
Serve as the primary M7/8 site interface and communication point for supplier quality matters and issues.
Attend local deviation review meetings and act as the quality liaison between suppliers and the site for the M7/8 project scope to assist deviation investigations.
Participate in the change control process as required.
Conduct quality systems audits of approved and potential suppliers of raw materials and components, service providers, and distributors for the M7/8 project.
Perform M7/8 project site audits when requested.
Represent and explain External Supplier Quality policies and procedures during regulatory audits.
Manage global and local supplier quality agreements, including writing, editing, reviewing, updating, and routing agreements for approval between the CSL New (M7/8) manufacturing location, service providers, and suppliers.
Support fiscal-year budget planning and ongoing forecasting for external audits.
Develop and maintain positive relationships with external quality functions at CSL’s critical suppliers in collaboration with Global Sourcing.
Lead a small team of auditors conducting external supplier and service-provider audits.