UroGen Pharma
Job Summary
The Associate Director Clinical Quality is a key role responsible for developing, implementing, and managing the Quality aspects of the company’s clinical development. This individual will ensure that clinical activities, including those conducted by outsourced partners, comply with Good Clinical Practice (GCP) regulations, internal Standard Operating Procedures (SOPs), and relevant national and international standards. Job Responsibilities
Clinical Quality Assurance Serve as the primary QA point of contact for clinical activities. Provide QA support to clinical development in accordance with GCP regulations. Participate in preparation, review, and approval of study-specific plans. Join sites monitoring visits. Collaborate with Clinical Department, external vendors and CROs to monitor trial performance, perform site audits, and address quality deviations promptly. Collaborate with Clinical Operations, Regulatory Affairs, and Data Management to ensure quality throughout the clinical trial lifecycle. Lead handling of clinical quality complaint issues, including investigations. Perform other related duties as required by management. Clinical Vendors Oversight Act as primary QA contact for outsourced clinical activities. Participate in evaluation, qualification, and selection of CROs and other clinical vendors, including vendor audits to ensure quality agreements, GCP, and regulatory compliance. Monitor vendor performance and quality metrics; identify and mitigate risks. Develop and maintain the Quality Management System (QMS) and review/approve Clinical SOPs to ensure alignment with FDA regulations and company policies. Ensure QMS compliance with current global regulatory standards (FDA, ICH, and others). Lead risk-based audit planning for clinical trials and vendors. Manage CAPAs for clinical findings. Auditing and Inspections Plan and conduct internal audits of clinical processes and documentation (e.g., Trial Master File) for accuracy and compliance. Lead preparation and support for regulatory inspections (e.g., FDA inspections) at the company and at investigator sites or CROs. Prepare audit reports, communicate findings to management, and track corrective actions. Training Provide expert guidance on GCP regulations to internal teams and external partners. Develop and deliver training on clinical quality and compliance topics as required. Clinical Quality Computerized Systems Ensure QA support and oversight for computerized systems with GCP impact in UroGen clinical studies according to FDA requirements and other applicable regulations. Support GCP computerized systems assessments and validation in cooperation with IT, contractors, and business owners. Work Environment
This is a full-time hybrid position. Onsite at UroGen offices in Princeton at least once a month. Travel may be required for clinical site visits/audits, vendor audits, and other business needs. Job Benefits
Medical Dental Vision 401k Match Paid Time Off Employee Assistance Program We are an Equal Opportunity Employer Seniority level
Director Employment type
Full-time Job function
Quality Assurance and Science Industries: Biotechnology, Research and Pharmaceutical Manufacturing Remainder of job postings and generic notices have been removed to focus on the core responsibilities and qualifications of the Associate Director, Clinical Quality role.
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The Associate Director Clinical Quality is a key role responsible for developing, implementing, and managing the Quality aspects of the company’s clinical development. This individual will ensure that clinical activities, including those conducted by outsourced partners, comply with Good Clinical Practice (GCP) regulations, internal Standard Operating Procedures (SOPs), and relevant national and international standards. Job Responsibilities
Clinical Quality Assurance Serve as the primary QA point of contact for clinical activities. Provide QA support to clinical development in accordance with GCP regulations. Participate in preparation, review, and approval of study-specific plans. Join sites monitoring visits. Collaborate with Clinical Department, external vendors and CROs to monitor trial performance, perform site audits, and address quality deviations promptly. Collaborate with Clinical Operations, Regulatory Affairs, and Data Management to ensure quality throughout the clinical trial lifecycle. Lead handling of clinical quality complaint issues, including investigations. Perform other related duties as required by management. Clinical Vendors Oversight Act as primary QA contact for outsourced clinical activities. Participate in evaluation, qualification, and selection of CROs and other clinical vendors, including vendor audits to ensure quality agreements, GCP, and regulatory compliance. Monitor vendor performance and quality metrics; identify and mitigate risks. Develop and maintain the Quality Management System (QMS) and review/approve Clinical SOPs to ensure alignment with FDA regulations and company policies. Ensure QMS compliance with current global regulatory standards (FDA, ICH, and others). Lead risk-based audit planning for clinical trials and vendors. Manage CAPAs for clinical findings. Auditing and Inspections Plan and conduct internal audits of clinical processes and documentation (e.g., Trial Master File) for accuracy and compliance. Lead preparation and support for regulatory inspections (e.g., FDA inspections) at the company and at investigator sites or CROs. Prepare audit reports, communicate findings to management, and track corrective actions. Training Provide expert guidance on GCP regulations to internal teams and external partners. Develop and deliver training on clinical quality and compliance topics as required. Clinical Quality Computerized Systems Ensure QA support and oversight for computerized systems with GCP impact in UroGen clinical studies according to FDA requirements and other applicable regulations. Support GCP computerized systems assessments and validation in cooperation with IT, contractors, and business owners. Work Environment
This is a full-time hybrid position. Onsite at UroGen offices in Princeton at least once a month. Travel may be required for clinical site visits/audits, vendor audits, and other business needs. Job Benefits
Medical Dental Vision 401k Match Paid Time Off Employee Assistance Program We are an Equal Opportunity Employer Seniority level
Director Employment type
Full-time Job function
Quality Assurance and Science Industries: Biotechnology, Research and Pharmaceutical Manufacturing Remainder of job postings and generic notices have been removed to focus on the core responsibilities and qualifications of the Associate Director, Clinical Quality role.
#J-18808-Ljbffr