Materials Control Manager

LFB30 LFB USA
Charlton, MA Full Time
POSTED ON 9/28/2022 CLOSED ON 1/23/2023

Job Posting for Materials Control Manager at LFB30 LFB USA

LFB has an immediate opening for a newly created position at our Charlton facility reporting to the VP, Industrial Planning & Supply Chain Management. The position could be a Manager/Senior Manager depending on qualifications and experience. SPECIFIC POSITION DUTIES (RESPONSIBILITIES, TASKS, ESSENTIAL FUNCTIONS) Compliance: Owns the Materials System, ensuring raw material control process and procedures are in compliance with applicable heath authorities’ requirements, e.g., FDA, EMA. Update and review procedures as needed working cross-functionally with involved areas. Chair/Co-Chair the Raw Materials Review Board that is responsible for evaluating new materials, reviewing vendor and material changes, and generating material specifications. Execute vendor, distributor, and material qualification processes, coordinating with QA Compliance and supported by functional experts. Ensures timely review of raw material exceptions. Owns raw materials tracking for quality compliance. Supply: Generates and delivers to Purchasing raw materials purchase plans based on production requirements, supply and release lead times, and stock levels. Coordinates raw materials on hand and release with Logistics, Manufacturing, Quality and Purchasing to ensure on-time supply. Coordinates raw material stock tracking with Logistics. Provides support as needed for the planning, monitoring, and distribution of drug product(s) to the global markets for which the drug product(s) is approved. Provides support to Logistics as needed. Reporting: Conducts vendor and material performance and compliance trending. Manages vendor and material life cycle performance tracking. Ensures traceability for required materials. POSITION QUALIFICATIONS (EDUCATION, EXPERIENCE, KNOWLEDGE, PHYSICAL REQUIREMENTS) Bachelor’s degree in science, math or related field required along with: At least 5 years in relevant areas, e.g., pharmaceutical operations, materials purchasing, compliance and management. Experience managing pharmaceutical manufacturing materials, or related products, in a GMP controlled environment. Experience with related requirements per US 21 CFR 210 and 211, and ICH Q8, Q9 and Q10. Analytical skills suitable to develop quantitative purchase plans and qualitative material compliance evaluations. Demonstrated organization skills to develop and execute plans, and achieve deliverables to provide on-time material delivery. Strong written, computer/electronic, and verbal communication skills for supporting internal and external staff and management interactions and communications.
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