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

Location
Hayward, California
Posted
Jul 29, 2021
Ref
oNvvffwM
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract
Job Summary:

This individual will be responsible for all supply chain related quality activities of Arcus’ antibody and small molecules programs


Responsibilities:

  • Responsible for quality oversite at clinical packaging, labeling, and 3PLsites.  This includes lot genealogy and traceability of labeled clinical kits/product.
  • Responsible for managing temperature excursion and product complaints related to packaging and logistics.
  • Responsible for all QP related interactions such as establishing QP to QP quality agreements, coordinating QP audits, obtaining documents such as Letter of Access.
  • Partner with several other functional areas (e.g., Quality Operations, Clinical Quality, CMC Regulatory, Supply Chain, Analytical Sciences, etc.) to ensure that clinical supplies are always available to patients across all programs (antibody and small molecules) and ensure that supply requirements are always aligned with development and manufacturing activities.
  • Monitor performance metrics and drive continuous improvements of CMO processes.
  • Manage all logistics and packaging process related deviations, CAPAs, and change controls.
  • Identify, as needed, areas of improving process and procedures in area of responsibility.
  • Other duties as assigned.

 
Qualifications (including knowledge & skills): 

  • 10+ 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.
  • Excellent verbal, written, and interpersonal communication skills.
  • Ability to interact with all levels of Arcus employees.

Arcus Biosciences is an equal opportunity employer.