Celcuity · 8 hours ago
Senior Auditor
United States
Full-time
Remote
Senior Level, Lead/Staff
$135K/yr - $165K/yr
10+ years expCelcuity is a clinical-stage biotechnology company focused on developing targeted therapies for cancer treatment. They are seeking a Senior Auditor to independently plan, lead, and execute complex internal and external GxP audits, ensuring compliance and maintaining high standards of product quality and safety.
BiotechnologyHealth CareHealth DiagnosticsTherapeutics
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
Qualification
Required
Bachelor's degree in health or life sciences; or relevant experience
10 plus (10+) years of experience in auditing and quality management systems in pharmaceutical, biotechnology, or medical device industry in a GxP regulated environment
Excellent written and verbal communication skills, with ability to influence and build credibility at all levels
Strong interpersonal skills for interacting with employees and leaders across various levels and functions
Attention to detail and ability to manage multiple processes and documentation requirements
Analytical and problem-solving skills to independently evaluate complex compliance issues
Strong technical and analytical skills with advanced knowledge in MS Office including Word, Excel, and PowerPoint
Experience with Veeva Quality Vault software required
Ability to work in a team or independently as required
Outstanding organizational skills with the ability to prioritize
Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment
Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization
Flexible and willing to learn; adapting to business and site needs in a dynamic environment
Maintain a positive, approachable and professional attitude
Preferred
Relevant professional certifications such as ASQ Certified Quality Auditor (CQA) or a Lead Auditor certification are highly preferred
Benefits
Annual performance incentive bonus
New hire equity package
Medical, dental, vision insurance
401(k) match
PTO
Paid holidays
Company
Celcuity
Celcuity is a biotechnology company translating discoveries of new cancer sub-types into expanded therapeutic options for cancer patients.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.1BKey Investors
Innovatus Capital Partners,Oxford Finance LLCInnovatus Capital PartnersVenrock Healthcare Capital Partners
2025-09-09Post Ipo Debt· $500M
2025-07-30Post Ipo Equity· $85M
2025-07-30Post Ipo Debt· $175M
Leadership Team
Brian Sullivan
Co-Founder, Chairman, CEO
Eldon Mayer
Chief Commercial Officer (CCO)
Recent News
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Company data provided by crunchbase