Asst Dir, Qual & Reg Assr, Clinical Trials

Quality Assurance Lead

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share : equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

Job Location : Saunders Research Building

Opening : Regular

Time Type : Full time

Scheduled Weekly Hours : 40

Department : 400981 Neuro-Ctr Health & Tech / CTCC

Work Shift : UR - Day (United States of America)

Range : UR URG 116

Compensation Range : $108,483.00 - $162,725.00

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries / hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Responsibilities : Leads the Quality Assurance team for clinical research conducted at CHeT. Ensures clinical data quality, regulatory compliance, and integrity of research documentation while collaborating with internal leaders and Principal Investigators. Ensures that CHeT is clinical trial "audit ready" and that there is full adherence to protect patients' safety, rights, and well-being. Manages, directs, and oversees all aspects of internal and external quality and compliance systems relating to routine daily operations, as well as establishes new quality standards and compliance systems supporting projects with territories outside of the United States and North America. Ensures compliance with Good Clinical Practices (GCP) and national and international regulatory requirements specific to the biopharma and medical technology sectors through the development, implementation, and oversight of the Quality Management System (QMS). Directs and oversees the day-to-day quality assurance and regulatory operations, including vendor qualification and management programs, training and development, and document management to ensure compliance and guarantee the highest standards of quality and safety. Directs the quality assurance strategic approach and growth to support ongoing and future clinical trials. Supports the project management (clinical operations), data management, and quality assurance teams during the conduct of clinical trials, including overseeing and directing the development of Standard Operating Procedures (SOPs) and other controlled documents. Maintains knowledge and expertise of quality standards as set forth in 21 CFR under the FDA and other regulatory agencies, the EU Clinical Trial Directives, and other regulations and guidelines, both national and international, relevant to clinical trial operations. Provides support to cross-functional teams and ensures the overall regulatory and GCP compliance with all applicable state and federal regulations, licensing requirements, and professional standards, and may include cGMP and oversight. Contributes as a subject matter expert to the University of Rochester central offices, to provide guidance, expertise, and assistance on high-priority, federally regulated research compliance areas, on behalf of the Center for Health and Technology.

Essential Functions :

• Oversees the strategic growth of quality assurance at the Center for Health and Technology and translates short-term plans into ongoing and day-to-day quality activities.
• Proactively provides QA leadership to the business strategy for CHeT by ensuring considerable organizational awareness (e.g., interrelationship of CHeT divisions and business priorities).
• Drives the implementation of the quality strategy. Acts as the QA point of contact for the defined trials and attends the meetings, and ensures quality is embedded in the decision-making processes for clinical research, including quality oversight for all trial sites, both national and international.
• Directs the activities of, mentors, and supervises the QA team members, which oversees all aspects of Good Clinical Practices (GCP), associated with CHeT's compliance with NYS, Federal, ICH, international regulations, and other regulatory authorities.
• Oversees, develops, and coordinates the delivery of appropriate GCP training on at least an annual basis for all CHeT personnel. Provides compliance consulting services to the University as needed.
• Develops and leads the implementation of a robust QMS that aligns with GCP and global regulatory requirements.
• Oversees internal and external audits to ensure compliance with global regulatory standards, including FDA, EMA, and ISO guidelines.
• Drives Corrective and Preventive Action (CAPA) processes to resolve quality and compliance issues effectively.
• Maintains and continuously updates SOPs to reflect current GCP guidelines and industry best practices.
• Collaborates with other departments to ensure seamless integration of quality processes throughout the clinical trial lifecycle.
• Supports and guides IT activities that directly affect data systems, servers, applicable software, etc., in support of compliance and security.
• Develops and maintains a robust change control program in compliance with quality and regulatory compliance standards for clinical research.
• Ensures all clinical trial activities comply with applicable regulations (FDA, EMA, etc.) and GCP standards.
• Serves as the primary liaison for regulatory agency interactions, including audits, inspections, and submissions.
• Monitors, interprets, and communicates changes in regulatory guidelines, advising on potential impacts to clinical operations.
• Leads the preparation and submission of regulatory documentation for investigational products, including Investigational New Drug (INDs) and New Drug Applications (NDAs).
• Implements and oversees risk-based quality management strategies tailored to biopharma and medical technology research activities in compliance with regulatory standards.
• Collaborates with cross-functional teams to identify, assess, and mitigate risks related to quality and compliance.
• Fosters a culture of quality, continuous improvement, and ethical research practices throughout the organization.
• Leads the design and implementation of training programs to educate faculty and staff on GCP and regulatory compliance standards.
• Recruits, trains, develops, and supervises the QA team.
• Integrates quality and regulatory processes, working collaboratively with cross-functional departments.
• Represents the organization in client / sponsor meetings, addressing quality and compliance aspects of clinical development projects.
• Builds and manages a high-performing quality and regulatory team to meet organizational goals and strategic vision for the QA team.
• Participates in external committees throughout the University as requested as a subject matter expert.
• Provides expertise and guidance to collaborating departments in interpreting and implementing government and agency guidelines to ensure GCP compliance, policies, and procedures across the University.

Other duties as assigned. Educations & Experience :

Knowledge, Skills & Abilities :

Licenses & Certifications :