Note: The job is a remote job and is open to candidates in USA. UroGen Pharma is a biotech company developing and commercializing treatments for urothelial and specialty cancers. The Associate Director, Clinical Quality is responsible for managing clinical quality activities, ensuring compliance with GCP and applicable regulations, overseeing vendors and audits, supporting inspections, and maintaining clinical quality systems.
Responsibilities
- 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
- 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
- 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
- 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
- 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
- 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
Skills
- 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
- 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)
- 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)
Benefits
- This is a full-time hybrid position. At least once a month onsite at UroGen offices in Princeton.
Company Overview
Company H1B Sponsorship