Rutgers, The State University of New Jersey is seeking a Director. Quality Assurance Service of GMP Facility for the Clinical Research Enterprise within Rutgers, Cancer Institute of New Jersey.
The Director, Quality Assurance Service is responsible for ensuring the quality and safety of engineered T cell therapy and other products and services by applying expert knowledge of quality principles and practices to the design, implementation, control, monitoring, assessment, and continuous improvement of GMP work processes. This role is responsible for overseeing and approving the design, development, implementation, and management of the quality management system for the Cell Therapy Program. The Director will lead QMS QA related projects and serve as an expert resource, providing quality oversight and ensuring regulatory and accreditation compliance for cellular therapy products manufacturing and distribution, laboratory services, and general support functions such as information systems, facilities and safety related to the Cell Therapy Program.
Among the key duties of this position are the following:
Develops Quality Management Program for Cell Therapy Program at the Cancer Institute.
Develops and maintains of all GMP required documentation (including SOPs, controlled forms for manufacturing, personnel training, GMP facility use and maintenance, equipment maintenance, reagents validation, deviations, CAPAs etc).
Provides quality oversight and GMP guidance to manufacturing, QC, engineering/facilities. Responsible for developing and maintaining processes and procedures to ensure appropriate quality oversight while demonstrating compliance with cGMP.
Develops and maintains phase-appropriate quality systems for both clinical and commercial manufacturing environments, including document management, deviations, CAPA, change control, training and auditing.
Approves the design and oversees the implementation of CINJ's cell therapy quality management system, including development, improvement and review of related SOPs, processes, IT solutions, and quality tools.
Minimum Education and Experience:
Bachelor’s degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management.
Minimum ten years related experience including any combination of: performing activities of a quality professional in a healthcare or drugs/biologics/medical devices GMP manufacturing setting or as an auditor of the regulatory agencies such as FDA, FACT etc., clinical, or technical work performed in a healthcare, laboratory, or drugs/biologics/medical devices manufacturing setting.
Minimum five (5) years management experience (includes supervision of Quality Assurance activities).
Required Knowledge, Skills, and Abilities:
Broad knowledge of quality assurance methods, principles, and practices, including basic statistical analysis and sampling techniques, auditing, process control, validation, and process improvement methodologies.
Expert knowledge of regulations and accreditation standards applicable to cGMP facility and cell therapy program.
Effective oral and communication skills.
Expert ability to apply knowledge of, and interpret applicable Federal, State, Local and international regulations and standards, technical specifications, and other guidelines to evaluate compliance.
Expert ability to analyze and interpret observational, operational, and quality data to monitor process performance and to determine if products and services are performing within defined specifications.
Expert ability to conduct studies and investigations for problem analysis, and risk assessments to assist with development of logical and well documented recommendations for process improvement and corrective actions.
Computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access, and PowerPoint.
Posting Number: 21ST1107
Location: Downtown New Brunswick
Internal Number: 131516
About Rutgers University
Rutgers, The State University of New Jersey, is a leading national public research university and the state's preeminent, comprehensive public institution of higher education. Rutgers is dedicated to teaching that meets the highest standards of excellence; to conducting research that breaks new ground; and to turning knowledge into solutions for local, national, and global communities. As it was at our founding in 1766, the heart of our mission is preparing students to become productive members of society and good citizens of the world. Rutgers teaches across the full educational spectrum: preschool to precollege; undergraduate to graduate and postdoctoral; and continuing education for professional and personal advancement. Rutgers is New Jersey's land-grant institution and one of the nation's foremost research universities, and as such, we educate, make discoveries, serve as an engine of economic growth, and generate ideas for improving people's lives.