Senior Manager Quality Assurance Supply Chain

5 days ago


Hayward, California, United States Arcus Biosciences Full time
Sr. Manager, Quality Assurance

Arcus Biosciences is seeking a highly experienced Sr. Manager, Quality Assurance to lead our supply chain quality activities. This role will be responsible for ensuring the quality of our clinical supplies and managing temperature excursion and product complaints related to packaging and logistics.

Key Responsibilities:
  • Lead all supply chain related quality activities, including quality oversight at clinical packaging, labeling, and 3PL sites.
  • Manage temperature excursion and product complaints related to packaging and logistics.
  • Partner with functional areas to ensure clinical supplies are available to patients and supply requirements are aligned with development and manufacturing activities.
  • Monitor performance metrics and drive continuous improvements of CMO processes.
  • Manage logistics and packaging process related deviations, CAPAs, and change controls.
Qualifications:
  • 10+ years of pharmaceutical industry experience in Quality Assurance with direct experience in working with and supporting clinical supply operations.
  • High school diploma or equivalent.
  • 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.
  • Excellent verbal, written, and interpersonal communication skills.

This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $160,000 - $173,000 USD annually.

Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other legally protected status.



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