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.

Responsibilities

• 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.

Qualifications

• 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.

Skills

• 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).

Education

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