Associate Director, Quality Assurance (Small Molecule QA)

Associate Director, Quality Assurance (Small Molecule QA)

Job Responsibilities:

• Lead quality oversight of GMP manufacturing and testing activities at Contract Manufacturing Organizations or Testing Labs

• Perform the review and approval of GMP documentations as it relates to Arcus small molecule clinical materials including specifications, batch records, quality investigations, in-process and product release testing data, validation protocols and reports, etc.

• Represent quality function and provide inputs in cross-functional CMC meetings

• 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.

• Review regulatory filing documents such as IND, IMPD.

• 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.

• 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

• Collaborate with functional groups to ensure consistent application and execution of key quality systems

• Responsible for the compliance and adherence to health authority standards and expectations. Operates in compliance with international GMP standards.

• Other duties as assigned.

Qualifications (including knowledge & skills):

• Bachelor's degree in Life Sciences with 12+ years of experience in Biotech or Pharma industry with strong quality background

• Comprehensive technical knowledge and experience in quality, especially working with CMOs and managing quality documentations from CMOs

• Experience working with small molecules pharmaceutical formulations (solid oral, lyophilized product, etc.)

• Experience using Veeva electronic quality document and QMS system is desirable

• 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.

This role will be based at our Hayward, CA location. 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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