Associate Director, Clinical Quality Assurance (Audits & Inspections) - Remote

Overview

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).

In Short

• 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.

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 relationships with business stakeholders and partners.
• Strong computer literacy in MS Word, Excel, Project, Visio, PowerPoint and Veeva Vault platform applications.
• Bachelor’s degree or higher in a medical or health sciences related field (advanced degree preferred).
• Ability to travel up to approximately 30% domestic and international, as needed.

Benefits

• Competitive market-based salary.
• Opportunity to participate in stock programs.
• Performance-based bonus.
• Comprehensive benefits package.