Senior Clinical Quality Assurance Auditor

Responsibilities: 

1. Conduct Audits: Plan and execute comprehensive audits of clinical trials. This includes auditing clinical trial master files, internal processes, investigator sites, contract research organizations (CROs), and other relevant entities to assess compliance with relevant regulations, guidelines, and standard operating procedures (SOPs). 
2. Host Audits/Inspections: Assist in hosting Sponsor audits and Regulatory Authority inspections. This includes providing support in coordinating the preparation and conduct of the audit/inspection, and in developing the responses (CAPA) to any findings,
3. Quality Assurance Documentation: Develop and maintain quality assurance documentation, including audit plans, audit reports, inspection readiness plans, and other relevant documents. Ensure accurate and timely documentation of audit findings, observations, and corrective actions taken. 
4. Training and Education: Provide training and guidance to internal staff and external stakeholders on quality assurance practices, regulations, and industry standards related to clinical research. Foster a culture of quality and compliance through educational initiatives and ongoing support. 

5. Quality Management System: Provide support in developing and maintaining the Quality Management System of the Organization, including support in the creation and revision of written procedures, conducting trending and metrics analysis for the QA activities

6. Process Improvement: Collaborate with cross-functional teams to identify areas for process improvement and develop strategies to enhance the efficiency and effectiveness of clinical quality systems. Implement best practices and drive continuous improvement initiatives. 
7. Regulatory Compliance: Stay updated with current regulations, guidelines, and industry trends pertaining to clinical quality assurance. Interpret and communicate regulatory requirements to ensure compliance across clinical research activities. 
8. Risk Assessment: Conduct risk assessments related to clinical quality assurance to identify potential vulnerabilities and areas of concern. Develop risk mitigation strategies and ensure appropriate controls are implemented. 
9. Collaboration and Communication: Foster strong working relationships with internal stakeholders, including clinical operations, regulatory affairs, data management, and other departments. Collaborate effectively with external parties, such as auditors, regulatory authorities, and vendors, to facilitate audits, inspections, and regulatory submissions. 

Requirements: 

• Bachelor's degree in a relevant scientific field (such as life sciences, pharmacy, or nursing). A higher degree (Master's or Ph.D.) is advantageous. 
• Minimum 5 experience in clinical quality assurance (8 preferred) , including conducting audits and inspections in the pharmaceutical, biotechnology, or clinical research organization (CRO) setting. 
• In-depth knowledge of applicable regulations and guidelines, such as Good Clinical Practice (GCP), International Council for Harmonisation (ICH), and relevant regional requirements (e.g., FDA, EMA). 
• Strong understanding of clinical trial processes, including study design, protocol development, data management, and adverse event reporting. 
• Excellent analytical and problem-solving skills, with the ability to critically evaluate complex data, identify trends, and propose effective solutions. 
• Demonstrated leadership abilities, including the ability to mentor and guide junior team members, and effectively collaborate with cross-functional teams. 
• Excellent communication skills, both written and verbal, with the ability to effectively communicate complex concepts and audit findings to various stakeholders. 
• Attention to detail, with a strong commitment to accuracy and quality in all work performed. 
• Relevant certifications, such as Certified Quality Auditor (CQA), Certified Clinical Research Professional (CCRP), or similar, are highly desirable. 
• Knowledge of risk-based quality management principles and experience with risk assessment methodologies is a plus. 
• Fluent oral and written English is required,  
• Intermediate proficiency in Word, Excel, and PowerPoint, is required.
• Ability to travel worldwide (Europe, North America, Asia and occasionally in other locations), on an as-needed basis.

• Annual compensation review with opportunities for professional growth
• 3 weeks of vacation plus paid December Holiday Closure
• 10 days paid personal/sick time
• 1 paid volunteer day / year
• A top tier, comprehensive Health / Medical plan for you and your family – Monthly premiums paid for by TRIO
• Up to 5% matching 401(k) Program
• Flexible working hours to promote work-life balance
• Monthly Internet Allowance to support working from home
• Remote work arrangements anywhere across the USA and receive a one-time home office allowance
• Mobile Phone Stipend available for qualifying positions
• Out-of-country Work: Employees can request to work internationally for a short period of time each year
• Employee Family Assistance Program to support you and your family during difficult times
• Employee Recognition Program to reward long-term employees
• Employee Referral Bonus Program

Teamwork · Passion · Integrity · Innovation