Associate Director, Clinical Quality

UroGen Pharma, Inc.; United States; On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

UroGen Pharma is seeking an Associate Director of Clinical Quality to develop, implement, and manage QA for the company’s clinical development programs. This role ensures GCP compliance for activities both in-house and with outsourced partners, aligning with SOPs and regulatory standards.

The position emphasizes risk-based QA, collaboration across functions, and proactive quality improvements. The role requires strong auditing experience, vendor management, and expertise in regulatory

Qualifications

• Minimum 5-7 years of experience in Clinical Quality Assurance, preferably in a pharma/biotech with outsourced trials.
• Strong understanding of U.S. and international regulatory requirements for clinical trials (ICH E6(R2), 21 CFR Parts 50, 54, 56, 312).
• Proven experience auditing CROs and clinical vendors.
• Experience in regulatory inspections preparation and participation.
• Ability to work independently, manage multiple priorities in a fast-paced environment.
• Proactive, strategic mindset with risk mitigation and process improvement.
• Excellent interpersonal and written communication skills in English.

Responsibilities

• Serve as the primary QA contact for clinical activities.
• Provide QA support to clinical development in line with GCP.
• Participate in study plans review/approvals.
• Join site monitoring visits and vendor audits.
• Collaborate with Clinical Ops, Regulatory Affairs and Data Management to ensure lifecycle quality.
• Lead CAPA investigations and corrective actions.

Skills

Quality Assurance

Regulatory Compliance

Auditing

Vendor Management

Documentation

Communication

GxP IT systems

Education

Bachelor's degree in life-science or health-related field

Advanced degree or certification in Quality Assurance (e.g., RQAP-GCP)

Tools

MS Office

Electronic Quality Management Systems

TMF/Quality documentation tools

Job description

Job Description

About the Company

UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers. We are fundamentally changing the way patients are treated for urologic cancers. Watch our New Horizons in Bladder Cancer event and discover why it's an exciting time to join UroGen® Pharma. Join us and be part of the team that will redefine the future of urological cancer treatment. Behind every UroGen innovation is the inspiration to empower uro-oncology patients with life-changing treatments. At UroGen, our people are our greatest asset. We cultivate a culture built on collaboration, creativity, and continuous growth. UroGen is a dynamic, rapidly expanding organization with an unwavering focus on improving the lives of patients because they deserve better.

Job Summary:

The Associate Director Clinical Quality is a key role responsible for developing, implementing, and managing the Quality aspects of 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 Requirements

Work Environment:

• This is a full-time hybrid position. At least once a month onsite at UroGen offices in Princeton.
• Travel will be required for clinical sites visits/audits, vendor audits, and other business needs.

Qualifications:

• Minimum of 5-7 years of experience in Clinical Quality Assurance, preferably in a pharmaceutical or biotech setting with outsourced trials.
• Strong understanding of U.S. and international regulatory requirements for clinical trials, including ICH E6(R2), 21 CFR Parts 50, 54, 56, and 312.
• Proven experience in auditing CROs and other clinical vendors.
• Demonstrated experience in preparing for and participating in regulatory agency inspections.
• Ability to work independently, manage multiple priorities, and meet deadlines in a fast-paced, dynamic environment.
• A proactive and strategic mindset with a focus on risk mitigation and process improvement.
• Excellent interpersonal relations, ability to connect and work independently.
• Effective verbal and written communication skills, with the ability to influence and collaborate with diverse stakeholders.
• Fully fluent in English (spoken, written).
• Experience in electronic Quality Management Systems.
• Experience in technical and SOP writing.
• Microsoft Office full proficiency (Word, Excel, PowerPoint).

Education:

• Bachelor's degree in a life-science or health-related field.
• Advanced degree or certification in Quality Assurance is a plus (e.g., RQAP-GCP).

Job Responsibilities

Clinical Quality Assurance

• Serve as the primary QA point of contact for clinical activities.
• Ensure quality assurance support to clinical development in accordance with GCP regulations.
• Participate in preparation/review/approval of study specific plans.
• Join sites monitoring visits.
• Collaborate with Clinical Department and external vendors and contract research organizations (CROs) to monitor trial performance, perform site audits, and address any quality deviations promptly.
• Collaborate with Clinical Operations, Regulatory Affairs, and Data Management to ensure quality throughout the clinical trial lifecycle.
• Lead the handling of clinical quality complaint issues, including investigations.
• Perform any other related duties as management may require from time to time.

Clinical Vendors Oversight

• Participate in the evaluation, qualification, and selection of CROs and other clinical vendors, including clinical vendor audits to ensure compliance with quality agreements, GCP, and other applicable regulations.
• Participate in vendor performance evaluation and quality metrics, identifying and mitigating potential risks.

Quality Management System (QMS)

• Support development, and review/approve Clinical Standard Operating Procedures (SOPs), ensuring they align with ICH / FDA regulations and company policies.
• Ensure the QMS is compliant with current clinical regulatory standards, including FDA regulations, ICH guidelines, and other relevant standards.
• Develop, implement and document risk-based audit plans for clinical trials and vendors.
• Manage Corrective and Preventive Actions (CAPAs) for clinical findings.

Auditing and Inspections:

• Plan and conduct internal audits of clinical processes and documentation (e.g., Trial Master File - TMF) to ensure accuracy and compliance.
• Lead the preparation and support for regulatory inspections (e.g., FDA inspections) at the company and at investigator sites or CROs.
• Prepare reports, communicate findings to management, and track the implementation of corrective actions.

Training:

• Provide expert guidance and interpretation of GCP regulations to internal teams and external partners.
• Develop and deliver training on clinical quality and compliance topics to relevant staff as may be required.

Clinical Quality Computerized Systems:

• Ensure quality assurance support and oversight to computerized systems with GCP impact in UroGen clinical studies according to FDA requirements, and other applicable regulations and guidelines.
• Support the GCP computerized systems assessments in cooperation with QA / IT / contractors / business owners.

Job Benefits

• Minimum of 5-7 years of experience in Clinical Quality Assurance, preferably in a pharmaceutical or biotech setting with outsourced trials.
• Strong understanding of U.S. and international regulatory requirements for clinical trials, including ICH E6(R2), 21 CFR Parts 50, 54, 56, and 312.
• Proven experience in auditing CROs and other clinical vendors.
• Demonstrated experience in preparing for and participating in regulatory agency inspections.
• Ability to work independently, manage multiple priorities, and meet deadlines in a fast-paced, dynamic environment.
• A proactive and strategic mindset with a focus on risk mitigation and process improvement.
• Excellent interpersonal relations, ability to connect and work independently.
• Effective verbal and written communication skills, with the ability to influence and collaborate with diverse stakeholders.
• Fully fluent in English (spoken, written).
• Experience in electronic Quality Management Systems.
• Experience in technical and SOP writing.
• Microsoft Office full proficiency (Word, Excel, PowerPoint).

Education:

• Bachelor's degree in a life-science or health-related field.
• Advanced degree or certification in Quality Assurance is a plus (e.g., RQAP-GCP).