AD, Clinical Quality Assurance (Audits & Inspections) (Office OR Remote)

This position supports the Clinical Quality Assurance function by providing GCP compliance oversight and support to Arcus Clinical Development therapeutic areas. The key activity of the role is providing expertise and guidance regarding applicable regulatory, Good Clinical Practice, and Arcus Standard Operating Procedure requirements for the conduct of clinical studies.  Primary responsibilities will include inspection readiness planning, management of health authority inspections and audits by external development partners, management of clinical audit programs, and oversight of consultant auditors.  This role will lead audits of investigator sites, internal functional/process audits, and audits of clinical vendors (GCP, GCLP, GPvP). As a GCP compliance expert, the AD/Director of Clinical Quality Assurance (Audits & Inspections) will utilize a risk-based and phase-appropriate strategy to prioritize GCP QA support for clinical functions, identify and escalate compliance issues, enable proactive decision making, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks. In addition, the AD/Director of Clinical Quality Assurance will partner with clinical functional areas to develop/revise Policies, SOPs, and Work Instructions.  This role will work closely with colleagues on the CQA (Study Compliance) team to support ongoing quality/compliance oversight and guidance for study management teams.  This role may mentor junior members of the CQA organization as they gain auditing experience, develop their auditing skills, and work toward becoming fully qualified GCP auditors. The AD/Director of Clinical Quality Assurance will actively contribute to the development, maintenance, and implementation of GCP-related Policies and SOPs. This role will participate in the management of systems relevant to the administration of the Clinical QMS in support of regulatory requirements for application in drug development and clinical trial execution within the Arcus Clinical Organization. This role supports investigations of quality events and provides oversight of corrective actions. This position reports to the Senior Director of Clinical Quality Assurance (Audits & Inspections).  Responsibilities:

• Identify and escalate significant compliance issues to Clinical QA and other relevant leadership.
• Maintain high level of expertise in global GCP regulations and internal policies and procedures that impact clinical study conduct.
• Lead external GCP/GCLP/GPvP audits of clinical vendors.
• Lead investigator site audits for clinical studies.
• Perform internal GCP audits of clinical functions.
• Manage annual audit programs to ensure compliance with Arcus auditing SOPs and Clinical Study Audit Plans.
• Oversee and support GCP-related CAPAs and process deviations.
• Establish relationship with CRO and development partner quality team members for the ongoing review of quality and compliance issues.
• Identify and anticipate trends in quality issues and collaborate with department management to ensure risk-managed solutions are implemented in a timely fashion
• Support Inspection Readiness activities and make recommendations for its continuous improvement
• Support health authority inspections of Arcus, clinical vendors, and investigator sites.
• Participate in quality and compliance initiatives, as assigned

Requirements:

• A minimum of 8 to 10 years of experience in a GCP related discipline.  Prior experience as a CRA, Study Coordinator, or in clinical study management is strongly preferred.
• Expert knowledge of global GCP requirements and applicable drug development regulations, including USA (FDA), European (EMA, MHRA), and ICH Guidelines.
• Knowledge of Good Pharmacovigilance Practices, or experience working in a Safety/PV role.
• Knowledge of Good Clinical Laboratory Practices.
• 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.
• A strong team player with great interpersonal and written communication skills
• Demonstrated strength in analytical and strategic assessment of regulatory compliance risks and the ability to articulate potential business impact.
• Must be flexible and comfortable with a risk-based approach to quality and ownership of quality across functional lines.
• Highly self-motivated, well-organized, and confident, with a solution-oriented mindset.  Able to develop innovative solutions to problems.
• Ability to influence people at different levels and negotiate cross-functionally in a matrix organization to resolve conflicts.
• Ability to build and sustain meaningful