Senior Auditor

Role Summary

Senior Auditor role, reporting to the Director, Quality Assurance. The Senior Auditor is a technical expert responsible for independently planning, leading, and executing complex internal and external GxP audits across Celcuity. This role focuses on assessing and mitigating high‑risk compliance issues and leading continuous improvement initiatives. The Senior Auditor helps maintain the highest standards of product quality, safety, and regulatory compliance.

Location:

Remote.

• Conduct vendor, investigator site, and internal audits according to applicable GxP requirements.
• Prepare detailed, high-quality audit reports and facilitate responses to audit observations.
• Support the vendor management program by performing initial audits of vendors.
• Manage the audit process through the quality management system.
• Lead or participate in strategic initiatives to continuously improve the Quality Management System (QMS), audit processes, and overall compliance to global standards.
• Provide guidance and training on GxP requirements to functional area personnel.
• Provide guidance and support during inspections and assist in developing responses to agency observations.
• Provide audit metrics to Executive Management.
• Working knowledge of regulatory requirements (FDA, EU) and related standards (GxP, CAP, CLIA).
• Other duties as assigned.

• Required:
  
  Bachelor’s degree in health or life sciences, or equivalent experience.
• Required:
  
  10+ years of experience in auditing and quality management systems in pharmaceutical, biotechnology, or medical device industry in a GxP regulated environment.
• Preferred: ASQ Certified Quality Auditor (CQA) or Lead Auditor certification.
• Required:
  
  Excellent written and verbal communication skills, with ability to influence and build credibility at all levels.
• Required:
  
  Strong interpersonal skills for interacting with employees and leaders across various levels and functions.
• Required:
  
  Attention to detail and ability to manage multiple processes and documentation requirements.
• Required:
  
  Analytical and problem‑solving skills to independently evaluate complex compliance issues.
• Required:
  
  Strong technical and analytical skills with advanced knowledge in MS Office including Word, Excel, and PowerPoint.
• Required:
  
  Experience with Veeva Quality Vault software.
• Required:
  
  Ability to work in a team or independently as required.
• Required:
  
  Outstanding organizational skills with the ability to prioritize.
• Required:
  
  Demonstrated independent and sound decision‑making skills; ability to think critically and make decisions in a fast‑paced environment.
• Required:
  
  Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization.
• Required:
  
  Flexible and willing to learn; adapting to business and site needs in a dynamic environment.
• Required:
  
  Maintain a positive, approachable and professional attitude.

• Working knowledge of regulatory requirements (FDA, EU) and related standards (GxP, CAP, CLIA).
• Strong technical and analytical skills with advanced knowledge in MS Office (Word, Excel, PowerPoint).

• Bachelor’s degree in health or life sciences; or relevant experience.