Senior Quality Assurance Auditor

🕒 March 18

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Celcuity

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

🔥 Funding within the last year

💰 $500M Post-IPO Debt - Celcuity on 2025-09

Biotechnology • Pharmaceuticals

Celcuity is a clinical-stage biotechnology company developing targeted therapies that comprehensively block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead product candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor in late-stage clinical development (including Phase 3 VIKTORIA trials) for HR+/HER2- advanced breast cancer and other indications such as prostate cancer. The company advances a focused pipeline of PAM pathway inhibitors, publishes clinical data, engages with investors and regulators, and is mission-driven to improve outcomes for cancer patients.

📋 Description

• 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.

🎯 Requirements

• 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. • Strong knowledge of regulatory requirements (FDA, EU) and related standards (GxP, CAP, CLIA). • Experience with Veeva Quality Vault software required.

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • 401(k) match • PTO • Paid holidays • Annual performance incentive bonus • New hire equity package