Assistant Director, Quality & Regulatory Compliance - University of Rochester Medical Center : Job Details

While this is a Quality and Regulatory Compliance role, we are seeking someone with a proven track record in leading quality and regulatory teams across global clinical research and/or clinical development projects

General Purpose

This role leads the Quality Assurance team at CHeT, overseeing all quality systems, compliance programs, and regulatory operations to ensure clinical research consistently meets the highest standards of data integrity, patient safety, and adherence to GCP, FDA, and international requirements. They direct SOP development, vendor qualification, training, and document management, while establishing new quality standards for trials in the U.S. and abroad. Serving as a subject matter expert, they advise University of Rochester leadership on federally regulated research compliance and support cross-functional teams to keep CHeT “audit ready” for ongoing and future clinical trials.

Essential Functions

• Strategic Leadership & Growth – Oversees the strategic growth and day-to-day operations of the Quality Assurance (QA) program at CHeT, ensuring quality is embedded in clinical research decision-making and aligned with business priorities. Acts as the primary QA point of contact for defined trials and provides organizational awareness of interrelated divisions and business goals.
• Quality Systems & Compliance – Develops, implements, and maintains a robust Quality Management System (QMS) that aligns with Good Clinical Practices (GCP), FDA, EMA, ICH, ISO, and other global regulatory requirements. Ensures all trial activities meet national and international compliance standards through risk-based quality management strategies, change control programs, and ongoing monitoring of evolving regulations.
• Audit & Oversight – Oversees internal and external audits, regulatory inspections, and interactions with agencies, serving as the primary liaison for submissions and compliance reviews (including INDs and NDAs). Directs Corrective and Preventive Actions (CAPA) and ensures continuous improvement of quality processes and SOPs.
• Training & Education – Designs, delivers, and coordinates GCP and compliance training for all CHeT personnel at least annually, fostering a culture of quality and ethical research practices. Provides compliance consulting services to the University and participates in external committees as a subject matter expert.
• Collaboration & Risk Management – Works cross-functionally with internal departments, trial sites, sponsors, and IT teams to integrate quality processes across the clinical trial lifecycle. Identifies, assesses, and mitigates risks related to quality and compliance, ensuring secure and compliant data systems.
• Team Leadership – Recruits, mentors, and supervises the QA team, building a high-performing group aligned with the organization's strategic vision. Represents CHeT in sponsor/client meetings and provides guidance on interpreting and implementing regulations across University research programs.

Experience

• Master's degree or other applicable degree and 10 years of experience in quality assurance and regulatory roles within the biopharma or medical technology industries required.
• Or equivalent combination of education and experience.
• Experience in quality and regulatory compliance with investigational products for biologics and medical devices.

Licenses & Certifications

• Relevant certifications such as American Society for Quality (ASQ), Certified Regulatory Affairs Certification (RAC), or Certified Quality Auditor (CQA) upon hire preferred

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