Senior Quality Assurance Auditor

Title: Senior Auditor

Location: Remote

Position Summary: We are seeking a Senior Auditor who will report into 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 plays a critical role in maintaining the highest standards of product quality, safety, and regulatory compliance.

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

• 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.
• Relevant professional certifications such as ASQ Certified Quality Auditor (CQA) or a Lead Auditor certification are highly preferred.
• 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.

About Us

Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth.

Our lead therapeutic candidate, gedatolisib, is an intravenously administered, potential first-in-class PI3K/AKT/mTOR (PAM) pathway inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Gedatolisib phase 3 clinical development programs are focused on the treatment of patients with HR+/HER2- ABC in the 1L and 2L settings. A Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer is ongoing.

Celcuity is an Equal-Opportunity Employer.

Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. For this role, the anticipated base pay range is $135,000-$165,000 DOE. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.