Job Summary:

The GCP Senior Auditor supports the Arcus Clinical Quality Assurance organization by independently conducting complex internal and external audits in accordance with Arcus’s Audit Program to ensure compliance with established policies, procedures, standards, and regulatory requirements and guidelines.

This position reports to Sr. Director or Director of Clinical Quality Assurance.

Job Responsibilities:

• Independently plans, schedules, conducts, and reports on a variety of GCP/GVP internal and external audits of Arcus studies, systems (including eTMF), and/or external suppliers to assure compliance with GxP, Arcus policies, procedures, standards and regulatory requirements and guidelines.
• Serves as Lead Auditor. May participate as a co-auditor, as requested.

• Reports the results of audits and any relevant findings in the Arcus electronic quality management system (Veeva Quality Vault, preferred). Clearly presents audit findings and/or other related audit information to appropriate departmental personnel, as required. Escalates issues to relevant management, as appropriate.

• Reviews audit responses including corrective/preventive actions and effectiveness checks by the auditees and follows to resolution, as appropriate.
• Assists CQA Management with the development of the Arcus audit program.
• Provides GxP consultation and support to Arcus project teams by serving as a resource during audits.
• Supports Quality Assurance activities during partner audits and/or regulatory inspections, as assigned.
• Identifies and escalates significant compliance issues to Quality Assurance leadership and relevant functional area leadership.
• Participates as member of clinical study teams for assigned therapeutic areas/studies, as assigned.
• Reviews regulated documents, such as SOP’s, Informed Consents, Protocols, etc.

• Maintains a high level of expertise in GCP drug development regulations, including USA (FDA), EU (EMA, MHRA) and ICH Guidelines and internal policies and procedures that may impact drug development.

• Supports strategic organizational quality and compliance process improvement initiatives (as assigned).

Qualifications:

• Excellent working knowledge and interpretation of GCP drug development regulations, including USA (FDA), EU (EMA, MHRA) and ICH Guidelines with experience in clinical quality assurance.
• Must have the ability to build and maintain positive relationships with department management, peers, and other colleagues across the organization.
• Self-motivated with the ability to take initiative, ownership and manage multiple responsibilities while shifting priorities quickly under tight timelines.
• Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
• Excellent oral and written communication skills.
• Demonstrated strength in analytical and strategic assessment of regulatory compliance risks and the ability to articulate potential business impact.
• Highly self-motivated, well-organized, confident, possess a solution-oriented mindset and able to develop innovative solutions to issues.
• Strong computer literacy in Microsoft Office Suite (Word, Excel, Project, Visio, PowerPoint, etc.) and Veeva Vault platform applications.

Education

• Bachelor of Science/ Bachelor of Arts in a relevant scientific discipline required.

Experience

• 5+ years in an audit role for pharmaceutical drug development, biotech (or equivalent) in a GCP and/or Safety/Pharmacovigilance related discipline.
• Previous Quality Assurance experience that provided the knowledge, skills and abilities to perform the expectations outlined in this job description. Auditor Certification, preferred.
• Experience with technologies used to conduct audits in a remote/virtual environment.

Travel, Physical Demands, and Work Environment

• Regularly required to operate computer and other standard office equipment for varying durations that may include extended periods of time.
• Regularly required to sit for long periods of time, and occasionally stand and walk.
• Willing to travel domestically and internationally approximately 40% of time, per business needs.

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Arcus Biosciences is an equal opportunity employer.