Xentria, a Chicago-based biopharmaceutical company focused on advancing drug development through patient engagement and strategic partnerships, is seeking a highly experienced Director of Clinical Quality Assurance. This pivotal role offers a unique opportunity to contribute to the development of novel drug therapies for rare diseases, like sarcoidosis, and shape the future of patient care. If you’re looking for challenging and rewarding Xentria Careers in a dynamic environment, this position may be the perfect fit.
Leading Quality and Compliance at Xentria
The Director of Clinical Quality Assurance will play a crucial role in establishing, maintaining, and enhancing Xentria’s Quality Management System (QMS). Reporting directly to the Senior Vice President of Quality Assurance, this leader will oversee the clinical development oversight program, ensuring compliance with Good Clinical Practice (GCP) guidelines and all relevant regulations throughout clinical trial execution. This includes:
- Quality Systems Development: Contributing to the development, implementation, and continuous improvement of the QMS and associated procedures.
- Proactive Risk Management: Identifying, analyzing, and mitigating potential risks to clinical trial quality through data analysis, risk assessments, and implementation of robust risk mitigation strategies.
- GCP Expertise and Guidance: Providing expert guidance on GCP and clinical compliance matters to internal teams, vendors, and partners.
- Quality Event Management: Evaluating and investigating GCP quality events, determining their impact on studies, and ensuring appropriate reporting.
- Inspection Readiness: Preparing for and participating in inspections by regulatory agencies (e.g., FDA, EMA) and audits by partners.
Responsibilities and Impact
The Director of Clinical Quality Assurance will have a broad range of responsibilities impacting all aspects of clinical quality and compliance:
- Audits and Inspections: Developing and executing a comprehensive GCP audit strategy, including planning, conducting, and reporting on internal, vendor, and site audits. This includes ensuring inspection readiness and leading responses to regulatory inspections.
- Clinical Quality Oversight: Collaborating with clinical trial management and clinical development teams to implement risk-based quality management, ensuring compliance with protocols, GCP, and other regulatory requirements.
- Training and Mentorship: Providing training and guidance on GCP and other relevant quality topics to internal staff and external partners. Mentoring and developing a team of quality professionals.
- Continuous Improvement: Driving continuous improvement initiatives within the QMS, leveraging quality indicators and data to identify trends and opportunities for enhancement.
- Collaboration and Communication: Building strong relationships with internal and external stakeholders, effectively communicating quality issues and ensuring alignment on compliance standards.
Qualifications and Experience
Xentria is seeking a candidate with a strong track record in clinical quality assurance within the pharmaceutical or biotechnology industry. Key qualifications include:
- Education: Bachelor’s degree in a health sciences or related field.
- Experience: Minimum of 10 years of experience in the pharmaceutical or biotechnology industry, with at least 5 years in a quality leadership role.
- Expertise: In-depth knowledge of GxP, FDA, EMA, and other regional regulations, including GCP, GMP, and GLP. Experience in various quality disciplines, such as auditing, risk management, vendor management, and CAPA management.
- Skills: Excellent communication, interpersonal, analytical, and problem-solving skills. Proven ability to lead and develop teams. Proficiency in Microsoft Office Suite and Quality Management Systems.
Join the Xentria Team
The Director of Clinical Quality Assurance position at Xentria offers a competitive salary range of $165,000 – $185,000, commensurate with experience and qualifications. This is a remote position with up to 20% travel.
If you are a passionate quality professional with a commitment to excellence and a desire to make a difference in the lives of patients, we encourage you to apply. Explore xentria careers and join a team dedicated to advancing innovative therapies for rare diseases.
