Senior Manager, CQA

Job Description

This role involves working with study management teams to ensure adherence to quality and regulatory compliance by conforming to domestic and international quality regulations and GCP guidelines. You will participate in daily QA Compliance operations following Arcus Biosciences' processes. You'll support the Clinical Quality Assurance function by providing GCP compliance oversight to Arcus Clinical Development areas. Provide expertise and guidance on regulatory, Good Clinical Practice, and Arcus Standard Operating Procedure requirements for clinical studies. Responsibilities include inspection readiness planning, managing health authority inspections, clinical audit programs, and overseeing consultant auditors. You will lead audits of investigator sites, internal process audits, and audits of clinical vendors (GCP, GCLP, GPvP). You will support clinical study teams by attending meetings, reviewing documents, and providing QA consultation on GCP-related issues. Identifying and escalating non-compliance issues to Clinical QA and Quality group leadership, including breach assessment. You will maintain expertise in global GCP regulations and internal policies affecting clinical study conduct. Collaborate with CRO quality counterparts, participate in internal and external GCP audits, and manage audit lifecycle activities in Veeva Quality Vault. Clearly present audit findings and work with auditees to complete corrective actions. You'll support QA during partner audits and regulatory inspections, and organizational quality improvements. Supporting Investigator Site Audits.

Qualifications

1. Bachelor of Science/ Bachelor of Art in a relevant discipline required (Biological or Life Sciences preferred). 2. 6+ years in pharmaceutical drug development in Clinical Quality Assurance and/or GCP-related discipline. 3. Quality Auditor / Manager certification preferred. 4. Excellent working knowledge and interpretation of ICH Guidelines and GCP domestic and international regulations. 5. Experience leading audits of GCP/GCLP/ GPvP vendors, investigator sites, and internal audits of clinical functional areas. 6. Experience managing inspection readiness activities and supporting FDA, EMA, and other health authority inspections. 7. Ability to build and maintain positive relationships with department management, peers, and other colleagues across the organization. 8. Self-motivated with the ability to take initiative, ownership and manage multiple responsibilities while shifting priorities quickly under tight timelines. 9. Customer-service orientation, high degree of professionalism, and ability to work with limited direction. 10. Excellent oral and written communication skills. 11. Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. 12. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. 13. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment 14. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information 15. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.

Benefits

- Opportunity to participate in stock programs - Performance-based bonus - Comprehensive benefits package