at CSL BEHRING LLC in BRADLEY, Illinois, United States
Job Description
Perform quality systems audits of approved and/or potential suppliers of raw materials, components, suppliers, contract manufacturers (CMO), distributors and service providers for CSL Sites. May also perform local site audits, as requested. Perform remote and paper-audits assigned per fiscal year. Prepare audit report and assign levels of compliance to each observe action based on established criteria. Deliver audit results to suppliers in a professional manner. Evaluate supplier corrective action plans are satisfactorily addressing the observation(s). Responsible for interpreting and making decisions based on company policies/procedures, regulatory agencies, local, state, federal and international regulations. Responsible for supplier quality agreements, global and local, which include writing, editing, reviewing, updating, and routing the agreements for approvals between CSL Manufacturing Site, service providers and suppliers. Assist the Manufacturing Site as the subject matter expert for Supplier Quality during inspections to mitigate compliance risk to the manufacturing site and to Supplier Quality. In collaboration with Global Sourcing, support supplier development and ongoing positive relationships with the external quality functions within CSL's Critical Suppliers. Attend local deviation review meetings and acts as liaison between Supplier and Local Site to assist deviation investigation processes. Participate in change control process on supplier and material changes. In collaboration with Assoc. Director/Sr. Manager, External Supply Quality, develop individual development plan which cultivates individual and organizational bench-strength. Up to 60% domestic and international travel required.
SPECIAL REQUIREMENTS:
Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered. Expertise/knowledge may be gained through employment experience or education. Such expertise/knowledge cannot be “quantified” by “time”. Required expertise/knowledge includes:
- Experience with GxP environment in the pharmaceutical industry.
- Understanding of required regulations, including FDA, PiC/S and European regulation, Therapeutics Goods Authority, and Canadian Health Authority.
- Auditing knowledge and experiences within the pharmaceutical industry.
- Experience working in a global, matrix organization.
- Process Improvement Techniques (Six Sigma, Lean).
- Risk Management Tools (FMEA).
- Quality and Problem-solving tools (Pareto charts, Cause and effect diagrams, statistical processes, Root cause analysis).
- Experience applying the requirements of Quality Management Standards (ISO 9000, ISO 13485).
- Supply Chain Management knowledge.
- Industry knowledge in Blood Plasma Therapies.
REQUIREMENTS: Bachelor’s degree (or foreign equivalent) in Pharmaceutical Engineering, Industrial Engineering, or related field plus 5 years of experience in the offered position or related position.
