Associate Director, Clinical Quality Assurance Auditor

About This Opportunity

We are representing a confidential biopharmaceutical organization seeking an Associate Director, Clinical Quality Assurance Auditor. This role will serve as the primary auditor for GCP/GLP/GVP audits and primary process owner of the clinical quality assurance audit program. You'll interface with internal and external stakeholders to assess and support GCP compliance with local and ICH-GCP guidelines, driving quality standards and regulatory compliance culture. This is an excellent opportunity to enhance quality culture while having a direct impact on late and early-stage clinical trials.

Responsibilities

• Serve as the CQA audit program process owner, accountable for day-to-day audit activities including coordinating, report reviews, response review, CAPA follow-up, and audit closures
• Lead audits for GCP, GVP, and GLP compliance, including investigator sites, CROs, vendors, laboratories, and internal functional areas
• Develop, implement, and maintain a risk-based global clinical audit program ensuring comprehensive coverage of company-sponsored trials and critical vendors
• Analyze and manage audit program metrics and trends to identify key compliance risks and improvement opportunities; communicate findings to senior management
• Lead inspection readiness activities for global health authority inspections, including mock inspections, SME training and preparation, and documentation review
• Design and create quality plans and metrics
• Oversee and coordinate with contract auditors on internal and external quality audits of clinical vendors and investigator sites
• Conduct quality reviews of key clinical documents (protocols, informed consent forms, clinical study reports, case report forms) and clinical SOPs
• Design and conduct GCP training for functional departments; act as primary trainer for the auditor program
• Support maintenance and continuous improvement of the clinical quality management system (QMS), including SOPs, training, and compliance metrics
• Provide mentoring and oversight to QA staff and foster a culture of quality and accountability across clinical teams
• Represent CQA in assigned projects and study/program team meetings to address quality issues

What We're Looking For

• Bachelor's degree in life sciences required
• 10+ years of progressive global quality/regulatory compliance experience in pharma/biotech or medical device industries, with hands-on role in quality audits and quality systems
• Current and strong working knowledge of United States Code of Federal Regulations and European regulations and guidance, including ICH-GCP requirements governing clinical research conduct and pharmacovigilance operations
• Experience with electronic Quality Management Systems and Trial Master File
• Auditor certification preferred
• Experience managing or supporting clinical trial or drug safety-related regulatory inspections is a plus
• Ability to lead cross-functional teams, independently prioritize work, and manage multiple priorities while maintaining quality and GCP compliance objectives
• Up to 60% travel may be required
• Location: Australia, Canada, New Zealand, United Kingdom, or United States

How We Work With You

Candidates apply directly through Get A Job.ai. Our talent team will review your application and conduct an initial screening. Qualified candidates will be submitted to our client for consideration. Please note: do not contact the client directly, as all communication should flow through Get A Job.ai to ensure a coordinated and professional process.

Pay

Pay details will be discussed during the screening process and are competitive based on experience and location.

Equal Employment Opportunity: Get A Job.ai is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.