Director of Clinical Quality Assurance (GCP) - Novel Drugs - Remote

Overview

Xentria is committed to advancing drug development through meaningful patient engagement and effective partnerships and has a track record of success in securing key collaborations in the life sciences industry. The team at Xentria is dedicated to helping early-stage products advance to the next stage of clinical development, getting them one step closer to commercial launch. Established in 2020 and headquartered in Chicago, Xentria collaborates closely with academic researchers, patient communities and biotechs as we commit to embracing the complexities of co-development projects. Our lead asset, XT MAB 16, is a monoclonal antibody, received Orphan Drug Designation by the FDA and EMA and is current in development for the rare disease of sarcoidosis.

Xentria is seeking an experienced Director of Clinical Quality Assurance to join their Quality Assurance team. This candidate will report directly to the Sr. Vice President of Quality Assurance. The Director of Clinical Quality Assurance will provide strong leadership and clinical development experience to support Xentria’s Quality Assurance and clinical compliance programs for our novel drug portfolio. This role will involve ongoing interaction with internal project team members, vendors, partners and project teams, influencing these internal and external stakeholders to successfully embed a robust Quality Assurance culture. This is a high-visibility role and will be directly involved in developing and continuously improving Quality Management System at Xentria. Director of Clinical Quality Assurance will be relied upon as a subject matter expert in GCP and Clinical Compliance with respect to the planning, execution, and close-out of clinical studies.

In Short

• Lead Clinical Quality Assurance efforts for novel drug portfolio.
• Develop and maintain Quality Management System.
• Participate in inspections and audits by regulatory agencies.
• Identify and mitigate risks related to quality in clinical trials.
• Provide training and support in GCP compliance.
• Collaborate with stakeholders to ensure inspection readiness.
• Manage multiple projects and maintain compliance standards.
• Report on quality activities to leadership teams.
• Supervise and mentor QA team members.
• Stay updated on GCP legislation and guidelines.

Requirements

• 10+ years in pharmaceutical/biotech industry; 5+ years in quality leadership.
• Expert knowledge of GxP, FDA, EMA regulations.
• Experience in auditing, GCP oversight, and vendor management.
• Strong analytical and problem-solving skills.
• Excellent interpersonal and communication skills.
• Bachelor’s degree in health sciences or related field.
• Experience with remote and digital audits.
• Ability to manage diverse projects concurrently.
• Knowledge of Quality Management Systems.
• Willingness to travel up to 20% domestically/internationally.

Benefits

• Comprehensive medical, dental, and vision coverage.
• Life insurance and disability benefits.
• 401K with company contribution.
• Paid time off (PTO) and employee assistance programs.
• Flexible spending accounts (FSAs) and wellness programs.
• Opportunity to work in a dynamic and innovative environment.
• Professional development and training opportunities.
• Collaborative and supportive team culture.
• Remote work flexibility.
• Engagement in meaningful patient-focused projects.