This job offer is no longer available
Lead Research QA Spec
University of Rochester
- Rochester, New York, United States
- Rochester, New York, United States
About
Facilitates and manages the Quality Management Systems (QMS) program. Leads and hosts compliance audits and regulatory inspections by competent regulatory authorities and external clients, and internal ICH Good Clinical Practice (GCP) Audits. Supports implementation of continuous improvement of the QMS. Develops, designs, and implements strategic audit plans based on regulatory standards, risk assessment, Department and client needs, as well as study functions. Develops internal standard operating procedures (SOPs) which guide all areas of the Quality Management System. Manages all related documentation within a document management system/(e)QMS. Analyzes trends in quality issue reporting and timeliness to ensure adherence to quality issue management requirements across project teams and processes. Provides expertise and guidance in interpreting regulations, agency guidelines and internal procedures to ensure continued compliance and process improvement. Develops relationships within the University as well as with counterparts in client organizations. Interfaces with management to discuss quality and compliance issues. Serves as the ambassador for the department by liaising with external study sponsors, internal departments and study teams to make recommended revisions to processes and procedures. Provides actionable insights from quality and operational data analysis and proactively works with the sponsor and internal teams to develop action plans to drive continuous improvement. Advises customer quality counterparts on the strategy for regulatory inspections. Collaborates in the preparation and management of internal and external inspections. Oversees the quality management of computer systems used in Clinical Trials to ensure compliance with governmental regulatory requirements. Provides expertise, training, and advice on clinical trial industry best practices, governmental regulations, ICH Guidelines, and other relevant quality compliance requirements of major regulatory agencies to Principal Investigators, study teams, study sponsors, and internal and external partners. Provides internal teams direction for continuous improvement. Responsible for mentoring internal staff not limited to Clinical Project Managers and Monitors with risk-based monitoring and risk-based plans. Presents educational programs and provides guidance to internal staff on compliance procedures. Reviews publications and professional offerings to learn about current auditing trends and findings to increase awareness of potential areas of concern. Develops and leads training efforts related to QA. Monitors changes and amendments to the applicable regulations to ensure that all processes and procedures remain compliant. Monitors trends in the QA industry to support continuous improvement. Other duties as assigned.
Minimum Education & Experience
Bachelor’s degree required Master’s degree preferred 10 years of relevant experience required or equivalent combination of education and experience required
Knowledge, Skills And Abilities
Expert knowledge of Quality Assurance and compliance in Good Clinical Practice (GCP) required Experience with electronic quality management systems and document control and database application required Excellent communication and organizational skills required Excellent critical thinking and problem-solving skills required Ability to manage multiple projects required Ability to make decisions that are guided by policies, procedures, and business plan required
LICENSES AND CERTIFICATIONS
Quality Assurance Audit Certification upon hire preferred
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law. #J-18808-Ljbffr
Languages
- English
Notice for Users
This job was posted by one of our partners. You can view the original job source here.