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