University of Rochester · 2 months ago
Asst Dir, Quality Assur, CMSU
Henrietta, NY
Full-time
Onsite
Mid, Senior Level
$108K/yr - $163K/yr
3+ years expThe University of Rochester is dedicated to a culture of equity and integrity, seeking to enhance the community through its values. The Assistant Director of Quality Assurance will provide technical support, oversee compliance with regulatory standards, and ensure the quality of clinical materials and processes within the Clinical Materials Services Unit.
Health CareMedicalUniversities
Responsibilities
Directs the activities of the Quality Assurance Compliance group within the Clinical Materials Services Unit (CMSU)
Oversees all aspects of Good Clinical Practices, Good Manufacturing Practices, and Good Laboratory Practices associated with CMSU’s compliance with State, Federal, and other regulatory authorities
Responsible for the hiring and professional development of staff
Oversees, develops, and coordinates the delivery of appropriate training for department personnel
Provides compliance consulting and technical guidance to employees, colleagues, and/or customers
Provides compliance support for the release of clinical trial supplies to allow for timely distribution in accordance with the international standards/regulations and client requirements
Conducts batch and production record reviews, as necessary, and liaises with external vendors to ensure compliance with project and regulatory standards
Responsible for administration of all internal Quality Assurance (QA) systems, including investigational drug and device procedures and processes
Acts as an input and approval authority for all department operating policies and standard operating procedures to ensure federal and international regulatory standards are met
Ensures all facilities and equipment remain in full compliance with State, Federal, and other regulations associated with applicable regulatory agencies
Manages, directs, and oversees policies and procedures governing the storage and security of department documentation systems
Implements, directs, and oversees stability and expiry/retest program for all on-going studies
Interacts directly with client, Project Manager, Principal Investigators, and analytical facility to obtain needed reports, extend, and terminate stability protocols as dictated by each project
Ensures that all QA requirements are met for projects
Responsible for the identification, budget/contract negotiation, implementation, validation, and user acceptance testing of all technology, including inventory management system
Ensures all staff are trained on new technology at time of implementation and as new hires come on board
Research industry trends to identify additional technology from which the department would benefit
Obtains proposals, vets vendors, and develops annual technology budget for new purchase and for routine maintenance of existing technology
Acts as a consultant to all clinical research personnel on matters of international regulatory standards to maintain internal and regulatory compliance
Participates in external and internal inspections from client companies and international regulatory authorities
Manages, directs, and oversees vendor certification and qualification programs and Internal Quality Audit Program
Qualification
Required
Bachelor's degree and 3 years of relevant experience required
Or equivalent combination of education and experience
Company
University of Rochester
The University of Rochester is a private research university located in Rochester, New York.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
$20.43MKey Investors
National Science FoundationUnitedHealthcareSociety to Improve Diagnosis in Medicine
2023-09-25Grant· $18M
2023-07-26Grant· $0.07M
2022-09-20Grant· $0.05M
Leadership Team
David Linehan
Chief Executive Officer
Recent News
2025-12-04
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