Associate Director GMP Quality

Hayward, CA, United States
Feb 27, 2021
Quality, Quality Control
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
About us:

Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs.

We are located in the San Francisco bay area, in the heart of the world's largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the “rule book” has not yet been written.

Job Summary:

This position is hands on role within Arcus Biotechnology QA organization. The responsibility of the incumbent is included but not limited to quality oversight and support of CMC operations as it relates to analytical/method transfer, technology transfer, product stability studies, and management of specifications. The incumbent will also provide support to the GMP Quality Management System, Implementation of Standard Operating Procedures and Governance of Quality Process across the Arcus network. Other tasks will include track and trend quality data, establishing traceability matrix for portfolio specifications and retest dates. This is role will work across functional groups to ensure adequate oversight across programs. The incumbent must be a team player, able to influence, and must be able to make tactical decisions.

Job Responsibilities:
  • Provide Quality Support to large and small molecule quality CMC operations.
  • Provide quality support and oversight to CMC (analytical/CMC operations) in managing stability for both small and large molecule programs.
  • Review and approve analytical method protocols. Manage current specification and specification changes for both large and small molecule programs.
  • Manage product batch retest dates for all Arcus molecules. Responsible for the issuance of internal release certificates.
  • Establish a traceability matrix for assigned retest dates
  • Establish a traceability matrix for Arcus CMC specifications
  • Establish a single source for Arcus stability and specification
  • Work with CMC to support QC related regulatory filings.
  • Work with CMC operations and Operations QA to troubleshoot and address OOT/OOS issues at CMOs
  • Manage current Standards and establish new Standards as needed for all QC activities including document review and approval
  • Manage the archival of all QC related data in the Veeva system
  • Support analytical method transfers
  • Support Deviations, CAPA's Change Control, Complaints, Risk Management, etc.
  • Provide Quality guidance to CMC organization as it relates to QC to ensure compliance with health authority expectations
  • Support regulatory filings and inspection as needed
  • Representation of QA at all levels of the organization by providing GMP guidance
  • Other duties as assigned

Qualifications (including knowledge & skills):

Bachelor of Science degree, in a related scientific discipline

Core Competencies, Knowledge and Skill Requirements
  • In-depth knowledge of GMPs (EU, US, AU, JP)
  • Experience in working with external partners and/or contract manufacturing
  • In-depth knowledge of Quality principles, concepts, industry practices and standards
  • Excellent verbal, written and interpersonal communication skills
  • Ability to work independently with scientific/technical personnel
  • Knowledge of risk management tools

Communication & Interpersonal Skills
  • Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail

Significant Contacts
  • Interacts with all levels of Arcus Bio employees including CMOs