New

Quality Manager (GMP Facility)

Rutgers University

life insurance

United States, New Jersey, New Brunswick

Sep 10, 2025

Position Details

Position Information

Recruitment/Posting Title	Quality Manager (GMP Facility)
Job Category	Staff & Executive - Research (Laboratory/Non-Laboratory)
Department	CINJ-OHRS Quality Assurance
Overview	RUTGERS CANCER INSTITUTE VISION, MISSION, AND CORE VALUES: VISION: Through our science, our evidence-based actions, our openness, and our respect for those we serve, we will advance cancer-focused research worldwide and reduce the burden of cancer in our catchment area. By engaging with and empowering our exceptionally diverse populations, and addressing their questions and fears, we will engender hope for cancer patients and their families and play a critical role in strengthening the fabric of our communities by gaining and protecting their trust and providing access to the outstanding oncology care each person deserves. MISSION: Our mission is to accelerate scientific discovery focused on understanding cancer, innovating cancer treatment, and improving cancer prevention; to provide outstanding, novel, and compassionate patient care; to provide evidence-based and culturally informed education to physicians, nurses, researchers, staff, and the community; and to achieve cancer health equity in our state through outreach to and engagement of our extraordinarily diverse communities. CORE VALUES: Curiosity and Discovery: encouraging an environment of continuous inquiry, creativity, and innovation to generate new knowledge Integrity: earning the trust of those we serve and each other through honesty, transparency, accountability, and continuous reflection Collaboration: approaching all opportunities with an understanding that together we are better and can achieve more; promoting and maintaining an environment of teamwork and shared knowledge Respect and Caring: consistently demonstrating caring, compassion, and respect through our words and actions Perseverance: maintaining an unwavering commitment to our mission; embracing change, overcoming obstacles, and creating and recreating the path to achieve our goals
Posting Summary	Rutgers, The State University of New Jersey is seeking a Quality Manager ( GMP Facility) in the Rutgers Cancer Institute, Office of Human Research Services Quality Assurance Department. The Manager, Quality Assurance Unit is responsible for ensuring the quality and safety of engineered T cell therapy and other products and services provided by GMP Facility 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 GMP Facility. The QA Manager will lead 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. The QA Manager will personally participate in execution of QA/QC activities for the GMP Facility as needed. Among the key duties for this position are the following: Develops Quality Management Program for Cell Therapy Program at RCI. Develops and maintains all of 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 GMP Facility quality management system, including development, improvement and review of related SOPs, processes, IT solutions, and quality tools. Monitors and arranges timely equipment preventive maintenance, services, calibration, certification. Monitors and arranges timely facility cleaning. Creates, maintains and revises all controlled documents for GMP Facility as required. Monitors all systems in the Facility for their performance status.
FLSA	Exempt
Grade	30S
Salary Details
Minimum Salary	105763.000
Mid Range Salary	133789.000
Maximum Salary	161814.000
Offer Information	The final salary offer may be determined by several factors, including, but not limited to, the candidate's qualifications, experience, and expertise, and availability of department or grant funds to support the position. We also take into consideration market benchmarks, if and when appropriate, and internal equity to ensure fair compensation relative to the university's broader compensation structure. We are committed to offering competitive and flexible compensation packages to attract and retain top talent.
Benefits	Rutgers offers a comprehensive benefits package to eligible employees, based on position, which includes: Medical, prescription drug, and dental coverage Paid vacation, holidays, and various leave programs Competitive retirement benefits, including defined contribution plans and voluntary tax-deferred savings options Employee and dependent educational benefits Life insurance coverage Employee discounts programs For detailed information on benefits and eligibility, please visit: http://uhr.rutgers.edu/benefits/benefits-overview.
Position Status	Full Time
Working Hours (per week)
Standard Hours	37.50
Daily Work Shift
Work Arrangement	This position requires a fully on-site work arrangement.
Union Description	MPSC - Legacy UMD
Payroll Designation	PeopleSoft
Seniority Unit
Terms of Appointment	Staff - 12 month
Position Pension Eligibility	ABP

Qualifications

Minimum Education and Experience	Bachelor's degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management. Equivalent experience, education and/or training may be substituted for the education requirements. Minimum seven (7) years specialized experience in performing activities of a quality assurance 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.) required. Within the seven (7) years of experience required above, at least five (5) years management experience (includes supervision of Quality Assurance activities) or oversight, management or consulting services for the new development and implementation of the GMP units required.
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. Strong work knowledges of quality system and regulatory requirements (21 CRF Part 11/210/211, 21 CFR 1271, ICH 8, ICH 9, ICH 10) in both U.S. and E.U. id required. 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. Highly proficient at preparing and delivering clear, concise, and effective written and oral communications. Highly proficient at establishing effective interpersonal relationships to meet the goals of the organization. Must be computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access, and PowerPoint.
Preferred Qualifications	Familiarity with FACT (Foundation for the Accreditation of Cellular Therapy) Accreditation Standards is a plus.
Equipment Utilized
Physical Demands and Work Environment	PHYSICAL DEMANDS: Standing, sitting, walking, talking and hearing. No special vision requirements. Lifting up to 25 lbs. WORK ENVIRONMENT: Laboratory environment. Exposure to blood or other body fluids. Exposure to hazardous chemicals. Moderate noise.
Special Conditions

Posting Details

Posting Number	25ST1947
Posting Open Date
Special Instructions to Applicants
Regional Campus	Rutgers Biomedical and Health Sciences (RBHS)
Home Location Campus	Rutgers University - New Brunswick
City	New Brunswick
State	NJ
Location Details

Pre-employment Screenings

All offers of employment are contingent upon successful completion of all pre-employment screenings.

Immunization Requirements

Under Policy 100.3.1 Immunization Policy for Covered Individuals, if employment will commence during Flu Season, Rutgers University may require certain prospective employees to provide proof that they are vaccinated against Seasonal Influenza for the current Flu Season, unless the University has granted the individual a medical or religious exemption. Additional infection control and safety policies may apply. Prospective employees should speak with their hiring manager to determine which policies apply to the role or position for which they are applying. Failure to provide proof of vaccination for any required vaccines or obtain a medical or religious exemption from the University will result in rescission of a candidate's offer of employment or disciplinary action up to and including termination.

Affirmative Action/Equal Employment Opportunity Statement

It is university policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, affectional or sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As an institution, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. For additional information please see the Non-Discrimination Statement at the following web address: http://uhr.rutgers.edu/non-discrimination-statement