Sr. Auditor, Clinical Quality Assurance

Location

Aliso Viejo, California, USA

Department Name

652-Clinical Admin-Pre Market Operations

Qualifications

1. Bachelor’s degree in life sciences or related field. 
2. Minimum of four (4) years of experience in clinical research and/or GCP related QA environment including auditing and/or external inspections (e.g., BIMO). 
3. Minimum of (2) years project management skills, including the ability to develop, prioritize and manage project plans and approaches for global efforts. 
4. In-depth understanding of global regulations and/or standards governing the conduct of clinical studies (e.g., 21 Code of Federal Regulations (CFR) Parts 11, 50, 54, 56, 812, 814, 820 and International Organization for Standardization (ISO) 14155 and 13485), Health Canada, EU MDR, ICH GCP (E6), GxP Guidelines and Regulations. 
5. Advanced working knowledge of QA principles including Quality Risk Management (QRM), Critical Thinking, and Quality by Design (QbD). 
6. Strong knowledge of compliance risks and quality controls. 
7. Experience in adult education and/or training clinical research personnel. 
8. Investigational medical device and/or neurovascular experience. 
9. Advanced global IDE clinical medical device experience in all phases of studies, including development, execution, and closure. 
10. Ability to concisely interpret clinical study results, safety reporting, data integrity, and metrics. 
11. Advanced skills in strategic thinking, evaluating, and solving issues with varying degrees of complexity and ability to provide meaningful analysis output, recommendations, and information delivery to management. 
12. Agile mindset and flexibility to meet changing needs and requirements for audit and/or inspections schedule. 
13. Demonstrate strong commitment to compliance, ethics, and accountability. 
14. Strong verbal and written communication skills, including strong technical writing skills. 
15. Proficient MS Office skills to include Word, PowerPoint, Excel, and Teams. 

1. Proficient experience in auditing and external inspections. 
2. Experience with EC/IRB/WIRB. 
3. Ability to efficiently handle multiple tasks and effectively meet timelines. 
4. Able to function independently within an environment that relies heavily on technology for communication and handling confidential information.

External-Facing Title

Sr Auditor, Clinical Quality Assurance

Posting Country

US - United States

Salary Range

$100,064 - $125,080 (Compensation may be higher/lower based on experience, education and skill sets)