Senior Associate Director, Clinical Quality & Compliance

UroGen Pharma, Inc.; United States; Hybride; USD 150 000 - 190 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Quality Assurance

Regulatory Compliance

Auditing

Vendor Management

Documentation

Communication

GxP IT systems

Formation

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

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

Outils

MS Office

Electronic Quality Management Systems

TMF/Quality documentation tools

Description du poste

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