Senior Manager, Clinical Quality Assurance

Responsibilities

• Work with study management teams to facilitate internal and external adherence to Quality and Regulatory Compliance by ensuring conformance to domestic and international quality regulations and GCP guidelines.
• Participate in day-to-day QA Compliance operations in conformance with Arcus Biosciences processes and procedures.
• Support the Clinical Quality Assurance function by providing GCP compliance oversight and support to Arcus Clinical Development therapeutic areas.
• Provide expertise and guidance regarding applicable regulatory, Good Clinical Practice, and Arcus Standard Operating Procedure requirements for the conduct of clinical studies.
• Manage inspection readiness planning, management of health authority inspections and audits by external development partners, management of clinical audit programs, and oversight of consultant auditors.
• Lead audits of investigator sites, internal functional/process audits, and audits of clinical vendors (GCP, GCLP, GPvP).

Qualifications

• Bachelor of Science/ Bachelor of Art in a relevant discipline required (Biological or Life Sciences preferred)
• 6 + years in pharmaceutical drug development in Clinical Quality Assurance and/or GCP-related discipline.
• Previous experience which provided the knowledge, skills and abilities to meet the expectations outlined in this job description.
• Quality Auditor / Manager certification preferred.
• Excellent working knowledge and interpretation of ICH Guidelines and GCP domestic and international regulations.
• Experience leading audits of GCP/GCLP/GPvP vendors, investigator sites, and internal audits of clinical functional areas.
• Experience managing inspection readiness activities and supporting FDA, EMA, and other health authority inspections.
• The ability to build and maintain positive relationships with department management, peers, and other colleagues across the organization.
• A self-motivated individual with the ability to take initiative, ownership and manage multiple responsibilities while shifting priorities quickly under tight timelines.
• An excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
• Excellent oral and written communication skills.