Director, Quality Assurance Service of GMP Facility

Rutgers University, United States

Updated: over 2 years ago
Location: New Brunswick, NEW JERSEY
Deadline: ;

Position Details


Recruitment/Posting Title Director, Quality Assurance Service of GMP Facility
Job Category Staff & Executive - Healthcare - Other
Department CINJ-OHRS
Overview
Rutgers Cancer Institute of New Jersey Vision, Mission, and Core Values: 
 
Our vision is to be a statewide, national and world leader of scientific discovery, transdisciplinary engagement, translation, patient care and education that improves outcomes for cancer patients and populations. 
 
We will accomplish this by conducting innovative basic, clinical and population research and cutting-edge patient-centered care that expands our understanding of the etiology and biology of cancer; facilitates the rapid translation of laboratory-based discoveries into human studies; develops new approaches and interventions for cancer prevention that decrease cancer incidence and mortality; and develops new and better therapies to decrease suffering and mortality from cancer. 
 
Core Values: Curiosity and Discovery, Integrity, Collaboration, Respect and Caring, Perseverance.
Posting Summary
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.
Position Status Full Time
Hours Per Week
Daily Work Shift
FLSA Exempt
Grade 36S
Position Salary
Annual Minimum Salary 113947.000
Annual Mid Range Salary 151820.000
Annual Maximum Salary 189694.000
Standard Hours 37.50
Union Description Non-Union
Payroll Designation PeopleSoft
Benefits

Information about the benefits provided to Rutgers employees can be found at: http://uhr.rutgers.edu/benefits/benefits-overview
Seniority Unit
Terms of Appointment Staff - 12 month
Position Pension Eligibility ABP

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).
Certifications/Licenses
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.
Preferred Qualifications
  • Master’s Degree.
Equipment Utilized
Physical Demands and Work Environment
Special Conditions

Posting Number 21ST1107
Posting Open Date
Special Instructions to Applicants
Regional Campus Rutgers Biomedical and Health Sciences (RBHS)
Home Location Campus Downtown New Brunswick
Location Details




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