Senior Quality Assurance Auditor
Celcuity
4 hours ago
Remote
United States
Operations
Position Summary
- Senior Auditor reporting into the Director, Quality Assurance, independently plans, leads, and executes complex internal and external GxP audits.
- Focuses on assessing/mitigating high-risk compliance issues and leading continuous improvement initiatives to support product quality, safety, and regulatory compliance.
Responsibilities
- Conduct vendor, investigator site, and internal audits per applicable GxP requirements.
- Prepare detailed, high-quality audit reports and facilitate responses to audit observations.
- Support vendor management by performing initial audits of vendors.
- Manage the audit process through the quality management system.
- Lead or participate in initiatives to continuously improve QMS, audit processes, and global compliance.
- Provide guidance and training on GxP requirements to functional area personnel.
- Support inspections and help develop responses to agency observations.
- Provide audit metrics to Executive Management.
- Maintain working knowledge of regulatory requirements (FDA, EU) and standards (GxP, CAP, CLIA).
Qualifications
- Bachelor’s degree in health or life sciences (or relevant experience).
- 10+ years’ experience in auditing and quality management systems in a GxP-regulated pharmaceutical, biotechnology, or medical device environment.
- ASQ Certified Quality Auditor (CQA) or Lead Auditor certification highly preferred.
Required/Preferred Skills
- Excellent written and verbal communication; ability to influence and build credibility at all levels.
- Strong interpersonal skills across functions and leadership.
- Attention to detail; ability to manage multiple processes and documentation.
- Analytical/problem-solving skills for complex compliance evaluations.
- Advanced MS Office skills (Word, Excel, PowerPoint).
- Veeva Quality Vault experience required.
- Ability to work independently or as part of a team; strong organizational and prioritization skills.
- Independent, sound decision-making and critical thinking in a fast-paced environment.
- Continuous improvement mindset; adaptable/willing to learn.
Benefits (as stated)
- Annual performance incentive bonus and new hire equity package.
- Medical, dental, vision, 401(k) match, PTO, and paid holidays.
- Senior Auditor reporting into the Director, Quality Assurance, independently plans, leads, and executes complex internal and external GxP audits.
- Focuses on assessing/mitigating high-risk compliance issues and leading continuous improvement initiatives to support product quality, safety, and regulatory compliance.
Responsibilities
- Conduct vendor, investigator site, and internal audits per applicable GxP requirements.
- Prepare detailed, high-quality audit reports and facilitate responses to audit observations.
- Support vendor management by performing initial audits of vendors.
- Manage the audit process through the quality management system.
- Lead or participate in initiatives to continuously improve QMS, audit processes, and global compliance.
- Provide guidance and training on GxP requirements to functional area personnel.
- Support inspections and help develop responses to agency observations.
- Provide audit metrics to Executive Management.
- Maintain working knowledge of regulatory requirements (FDA, EU) and standards (GxP, CAP, CLIA).
Qualifications
- Bachelor’s degree in health or life sciences (or relevant experience).
- 10+ years’ experience in auditing and quality management systems in a GxP-regulated pharmaceutical, biotechnology, or medical device environment.
- ASQ Certified Quality Auditor (CQA) or Lead Auditor certification highly preferred.
Required/Preferred Skills
- Excellent written and verbal communication; ability to influence and build credibility at all levels.
- Strong interpersonal skills across functions and leadership.
- Attention to detail; ability to manage multiple processes and documentation.
- Analytical/problem-solving skills for complex compliance evaluations.
- Advanced MS Office skills (Word, Excel, PowerPoint).
- Veeva Quality Vault experience required.
- Ability to work independently or as part of a team; strong organizational and prioritization skills.
- Independent, sound decision-making and critical thinking in a fast-paced environment.
- Continuous improvement mindset; adaptable/willing to learn.
Benefits (as stated)
- Annual performance incentive bonus and new hire equity package.
- Medical, dental, vision, 401(k) match, PTO, and paid holidays.