Associate Director, Project Quality, Vendor Qualification

CSL Plasma•Kankakee, IL

About The Position

Provides Quality oversight of external supplier and vendor activities for the Module 7/8 Site Expansion Project at CSL Behring’s Kankakee site. The project adds Ig production activities—from plasma thawing through sterile filling—to a new fill-finish facility. The role ensures efficient, compliant end-to-end processes for GxP-related raw material suppliers, service providers, and distributors, and leads a small team of auditors conducting external supplier and service-provider audits. The position works with External Supply Quality and Global Sourcing to manage supplier qualification and audit programs, develop risk-management and monitoring approaches, serve as the project’s supplier-quality interface, and support site deviation and change-control processes. It also manages supplier quality agreements, represents External Supplier Quality policies during regulatory audits, and supports audit-budget planning and forecasting.

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 authorities.
Strong industry knowledge, including CSL Behring’s process flow and the plasma business, and experience with internal and external audits in the industry.
Comfort working in a global, matrix organization.
Strong organizational skills, time management, and planning.
Cross-cultural sensitivity, perseverance, and strong written and verbal communication.
Demonstrated experience directing others and delegating.
Managerial courage and sound decision-making.
Proficiency in building consensus and escalating issues.
Strong negotiation, influencing, and collaboration skills.
Fluency in written and spoken English.
Demonstrated ability to work cross-functionally with internal and external stakeholders.
Effective presentation and meeting skills with people at all organizational levels and external colleagues and collaborators.

Nice To Haves

Advanced degree in a relevant scientific discipline.

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.
Identify and apply best-in-class practices to establish risk-management tools and supplier and raw-material monitoring concepts.
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 a quality liaison between suppliers and the site to assist deviation investigations.
Participate in the change-control process as required.
Perform quality-systems audits of approved and potential suppliers of raw materials and components, service providers, and distributors for the M7/8 project; perform 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 new CSL M7/8 manufacturing location, service providers, and suppliers.
Support fiscal-year budget planning and ongoing forecasting for external audits.
Work with Global Sourcing to develop and maintain positive relationships with external quality functions at CSL’s critical suppliers.
Lead a small team of auditors conducting audits of external suppliers and service providers.