GCP Auditor (Contract)
About The Position
Do you have the passion and commitment to join a team whose mission is to develop treatments that have a clear and profound impact on people with rare diseases? Does it excite you to be a part of a company developing potential new treatments that could dramatically improve the lives of people with limited to no treatment options? Named one of the Top Places to Work by The Boston Globe , X4 is an exceptional place, focused on open communication and collaboration and dedicated to each other, our partners, and the medical community. With the April 2024 U.S. approval of our first drug XOLREMDI™ (mavorixafor), we have made great progress in advancing our patient-centric mission and in evolving the company into a fully integrated pharmaceutical company. But there is so much left to do! We are continuing to explore global opportunities for mavorixafor in its first indication, while also advancing mavorixafor for people with chronic neutropenia through an ongoing pivotal, global Phase 3 clinical trial. We recognize that developing innovative, new medicines is challenging, but we embrace this challenge to truly make progress for patients each day. If you feel you would be a good fit for X4, we invite you to share with us your aspirations and career goals. At X4 you will find… A team that values grit and passion of innovative science. The opportunity to leverage your knowledge of Quality to support our innovative science and allow you to have a major impact on our mission to support our patients. A collegial environment with a team-based approach, where our mission drives our values, behaviors, and creativity. Accountabilities and Responsibilities: We are seeking an experienced GCP Auditor to support and lead quality assurance activities across clinical development programs. This role is responsible for executing risk-based audit strategies, ensuring compliance with global GCP/GLP/GVP regulations, and providing independent quality oversight of clinical trials, systems, and vendors. The ideal candidate brings strong auditing expertise, a proactive risk-based mindset, and the ability to partner cross-functionally to drive inspection readiness and continuous improvement. This is a hybrid position with two days onsite. This is a 6+ month contract with the potential to convert to full time.
Requirements
- Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field
- 8+ years of experience in QA, Clinical, or related GxP environment
- 5+ years of GCP auditing experience
- CAPA management, risk assessments, and audit strategy development
- Ability to work independently with minimal oversight
- Excellent communication and stakeholder management abilities
- Proven ability to manage multiple priorities in a fast-paced environment
Responsibilities
- Independently plan, conduct, and report risk-based GCP audits, including:
- Internal systems and process audits
- Clinical study report and eTMF/TMF audits
- CRO and vendor audits
- Investigator site audits
- Support the development and execution of the annual GCP audit plan aligned with clinical programs and risk priorities
- Assess audit findings and Quality Issues and support the development, review, and closure of CAPAs
- Perform risk assessments and trend analysis to identify compliance gaps and drive continuous improvement
- Support and contribute to regulatory inspection readiness activities and health authority inspections
- Proactively identify compliance risks and escalate critical findings with recommended mitigation strategies
- Provide quality oversight of CROs, vendors, and clinical investigators, ensuring compliance with GCP and internal standards
- Lead or support vendor qualification, auditing, and performance monitoring
- Establish and maintain Quality Agreements with vendors
- Maintain and support the approved vendor list and supplier oversight processes
- Serve as a Quality representative on clinical study teams, providing guidance on GCP compliance and risk management
- Provide quality input on protocol deviations, issue management, and compliance-related risks
- Perform quality review of key clinical and regulatory documents (e.g., protocols, IBs, DSURs) to ensure GCP compliance
- Promote a proactive inspection readiness mindset across study teams and stakeholders
- Develop, implement, and maintain SOPs, audit procedures, and GCP quality systems
- Maintain audit documentation, metrics, and systems (e.g., Veeva Vault)
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What This Job Offers
Career Level
Mid Level
