Manager, Quality Assurance (Supply Chain) - REMOTE
Arcus Biosciences, Inc.
Remote
manager
quality assurance
assurance
supply
supply chain
remote
supply
supply chain
quality assurance
assurance
management
packaging
logistics
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September 27, 2022
Arcus Biosciences, Inc.
Hayward, CA, CA
FULL_TIME
Job Responsibilities:
* Reports to the Associate Director, Supply Chain Quality Assurance and will play a crucial role in supporting Arcus' growing supply chain network
* Responsible for helping implement new supplier quality initiatives, including supplier lifecycle management process, risk, and knowledge management
* Responsible for assisting with supply chain related quality activities of Arcus' antibody and small molecules programs
* Responsible for assisting with quality oversite at clinical packaging, labeling, and 3PLsites.
* Responsible for managing temperature excursion and product complaints related to packaging and logistics.
* Responsible for managing part number generation and maintenance.
* Monitor performance metrics and drive continuous improvements of CMO processes.
* Other duties as assigned.
Qualifications (including knowledge & skills):
* 8+ years of pharmaceutical industry experience in Quality Assurance with direct experience in working with and supporting clinical supply operations.
* Solid understanding of clinical supply chain and logistics
* Solid understanding of EU Qualified person requirements
* In depth understanding and knowledge of US, EU, CN, AU, JP quality requirements.
* Experience in working with external partners and / or contract manufacturing organizations.
* Solid understanding of quality principles, concepts, industry practices, and standards.
* Ability to work independently, a self-starter, and hands on in a fast-paced environment.
* Excellent verbal, written, and interpersonal communication skills.
* Ability to interact with all levels of Arcus employees.
#LI-Remote
#LI-JC1
* Reports to the Associate Director, Supply Chain Quality Assurance and will play a crucial role in supporting Arcus' growing supply chain network
* Responsible for helping implement new supplier quality initiatives, including supplier lifecycle management process, risk, and knowledge management
* Responsible for assisting with supply chain related quality activities of Arcus' antibody and small molecules programs
* Responsible for assisting with quality oversite at clinical packaging, labeling, and 3PLsites.
* Responsible for managing temperature excursion and product complaints related to packaging and logistics.
* Responsible for managing part number generation and maintenance.
* Monitor performance metrics and drive continuous improvements of CMO processes.
* Other duties as assigned.
Qualifications (including knowledge & skills):
* 8+ years of pharmaceutical industry experience in Quality Assurance with direct experience in working with and supporting clinical supply operations.
* Solid understanding of clinical supply chain and logistics
* Solid understanding of EU Qualified person requirements
* In depth understanding and knowledge of US, EU, CN, AU, JP quality requirements.
* Experience in working with external partners and / or contract manufacturing organizations.
* Solid understanding of quality principles, concepts, industry practices, and standards.
* Ability to work independently, a self-starter, and hands on in a fast-paced environment.
* Excellent verbal, written, and interpersonal communication skills.
* Ability to interact with all levels of Arcus employees.
#LI-Remote
#LI-JC1
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