Manager/Sr. Manager, Quality Assurance (Supply Chain Quality)

Location
Remote
Posted
May 09, 2022
Ref
ojNyjfwH
Required Education
Bachelors Degree
Position Type
Contract

Manager/ Sr. Manager Quality Assurance (Supply Chain Quality)

  

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.

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