Associate Director, Quality Assurance (Small Molecule Quality Operation)

Job Responsibilities:

• Responsible for the compliance and adherence to health authority standards and expectations. Operates in compliance with international GMP standards.
• Perform the review and approval of GMP documentations as it relates to the manufacturing of Arcus small molecule clinical materials including batch records, quality investigations, in-process and product release testing data, validation protocols and reports, etc.
• Manage GMP documentations generated by CMOs (i.e. specifications, executed batch records, CoAs, testing data package, etc). Ensure these documents remain complete and current in Arcus electronic document system.
• Other duties as assigned.
• Review regulatory filing documents such as IND, IMPD.
• Collaborate with other quality team members and support process improvements and risk assessments; benchmarks internal and external quality practices to identify and implement efficient and effective practices
• Work with cross functional groups (Pharmaceutical Development, Regulatory, Supply Chain, etc.) to create, route, approve, and track GMP documentations in Arcus QMS system, including change controls, deviations, CAPAs, complaints, audit findings etc.
• Lead quality oversight of GMP manufacturing and testing activities
• Collaborate with functional groups to ensure consistent application and execution of key quality systems

Qualifications (including knowledge & skills):

• Proven ability to work collaboratively with a broad range of people, background and functions along with excellent communication skills.
• Excellent knowledge of all regulatory guidelines relevant to GMP.
• Bachelor’s degree in Life Sciences with 12+ years of experience in Biotech or Pharma industry with strong quality background
• Comprehensive technical knowledge (preferably small molecule) and experience in quality, especially working with CMOs/managing quality documentations from CMOs
• Experience using Veeva electronic quality document and QMS system is desirable

This role can be based at our Hayward or Brisbane, CA locations. The anticipated salary range for fully qualified candidates applying for this position is $170,000 - $185,000 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
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