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Quality Assurance Senior Manager, Japan

Company: CSL Behring
Location: Lawrence
Posted on: November 22, 2021

Job Description:

About CSLWith operations in 35+ nations and -27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL---s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!Job DescriptionResponsibilities:--- Leads/coordinates Quality Assurance activities to ensure compliance with company standards and regulatory guidelines--- Ensures compliance with established internal specifications, standard operating procedures (SOP) and government regulations--- Coordinates and manages complex deviations, task forces and communication to ensure compliant release system for corresponding market--- Responds to questions from authorities (Swissmedic, FDA, etc.) to ensure timely product release--- Supports submission of test samples, certificates and batch documentation for authorities (Swissmedic, FDA, etc.)--- Provides technical guidance and recommends improvements to quality systems and processes--- Initiates changes to SOPs when a deviation from regulation is identified or a system process is not functional based on the current instructionsQualifications:--- University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)--- 7+ years' GMP experience in pharmaceutical/biotech/or other regulated industry--- Experience within a global matrix organization--- Knowledge of appropriate regulatory requirements including GMP/GQPDifferent qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

Keywords: CSL Behring, Lawrence , Quality Assurance Senior Manager, Japan, Executive , Lawrence, Kansas

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