Manager, Quality Assurance (Label)

Description

MANAGER, QA LABEL

Arcus Biosciences is currently seeking a Label Manager for our Hayward, CA location or Remote. The Label Control Manager will manage and oversee all functional activities associated with the production of clinical trial labels in accordance with Global Regulatory requirements. The position will report to the Assoc. Director Supply Chain Quality Assurance.

Responsibilities Include But Are Not Limited To

• Establish Process and Manage label design and CMO activities to ensure label production goals and efficiencies are met with oversight to Arcus requirements, regulatory compliance, and Arcus Partner (as applicable) requirements.
• Function as Subject Matter Expert (SME) and keep current on Clinical Label materials and printing regulations and technologies that may benefit Arcus Biosciences.
• Assist the Supply Chain, Clinical Operations and Regulatory Affairs (CMC) with any technical information on labels. Manage approved labels in a label management database to ensure accurate and up to date labeling is available and accessible at all times.
• Maintain knowledge of current rules and regulations governing labeling activities.
• Assess text for compliance with labeling requirements in conjunction with Regulatory.
• Reviewing and approving artwork and change control related to labeling activities at CMOs.
• Serve as main point of contact for CMOs performing label and translational activities for Arcus Biosciences.
• Develop, manage, and execute projects, plans and programs relating to label design, and approval control functions for continued improvement of the overarching process.
• Develop, review and present labeling metrics; and complete Quality Investigations in a timely/ accurate manner to put corrective actions in place to prevent recurrences and report to Management.
• Provide Quality Support at CMOs with respect to review of MBRs, EBRs, lot genealogy, and address process related issues as needed.
• Support regulatory filings and inspection as needed.
• Assist in other areas of Supply Chain QA as needed
  
  

Qualifications

Required Experience / Education:

• 4-year degree or 10 years of Label Experience
• At least 3 years in related label and packaging field
• Knowledge of label construction and materials
• Intermediate computer knowledge
• Highly organized with the ability to manage complex projects and timelines for all aspects of E2E labeling
• Experienced processing and assessing translations of labeling a plus.
  
  

Preferred Experience / Education

4-year degree plus higher degree

This role can be based at our Hayward, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $125,000 - $140,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers .

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 identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets