CrawlJobs Logo

Cellular Therapy Program Quality Manager

urmc.rochester.edu Logo

University of Rochester

Location Icon

Location:
United States of America , Rochester

Category Icon
Category:
Health and Beauty

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

70197.00 - 105295.00 USD / Year
Save Job
Save Icon
Apply Position

Job Description:

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

Job Responsibility:

  • Develops and implements programs, policies, and practices to ensure that all departments are in compliance with organizational and governmental standards and makes recommendations for updates
  • Maintains compliance with all country-mandated regulatory requirements
  • Documents legal regulations that might affect the organization's policies and procedures
  • Develops and delivers training programs to enhance employee awareness and adherence to safety and quality standards
  • Maintains communications with leadership regarding quality and safety activities
  • Coordinates and conducts the assessment of internal controls to ensure compliance as required by regulatory commissions/authorities
  • Develops programs and processes to manage complaint cases brought to regulatory authorities and develops process improvements to avoid future complaints
  • Manages a domain of quality and/or patient safety
  • Coordinates and facilitates credible comprehensive systematic analysis and when applicable, assists in the development of associated risk reduction strategies in a timely manner, with associated reporting to state regulatory agencies as required
  • Facilitates interdepartmental team effectiveness
  • Advises and guides multiple clinical departments to ensure compliance with federal and state regulatory requirements and accreditation standards
  • Provides support and serves as a liaison between hospital Quality Improvement leadership and department quality physician leadership and quality administrative support to ensure departmental QAPI plans are effective and aligned with hospital management plan quality and safety goals and hospital policy
  • Addresses organizational Quality/Safety needs
  • Monitors and investigates patient safety events reported in the safety event reporting system
  • In coordination with clinical departments, identifies safety events for review and evaluation by Risk Management and Quality Improvement leadership for possible comprehensive analysis or would benefit from department level review
  • Provides support for regulatory survey activity, including announced, unannounced and desk or written activities

Requirements:

  • Bachelor's degree and 5 years of relevant experience required
  • Or equivalent combination of education and experience

Additional Information:

Job Posted:
March 08, 2026

Employment Type:
Fulltime
Icon
University of Rochester - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Cellular Therapy Program Quality Manager

New

Rn Coordinator - Transplant And Cellular Therapy Data

Supports the Memorial Healthcare System Transplant and Cellular Therapy Program ...
Location
Location
United States , Pembroke Pines
Salary
Salary:
Not provided
Memorial Healthcare System
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelors (Required)
  • Registered Nurse Compact License (RN LICENSE COMPACT) - Compact RN Multistate
  • Registered Nurse License (RN LICENSE) - State of Florida (FL)
  • One (1) year database experience with data management preferred
  • Oncology experience, including Bone Marrow Transplant (BMT) experience, is preferred
  • Strong Oncology experience
  • Work experience/skill with Word, Access, Excel, EPIC, and Outlook preferred
  • Requires critical thinking skills, decisive judgment, and the ability to work with minimal supervision
  • Must be able to work in a stressful environment and take appropriate action
  • Ability to independently monitor and audit clinical information
Job Responsibility
Job Responsibility
  • Supports the Memorial Healthcare System Transplant and Cellular Therapy Program by collecting and reporting programmatic, quality, and performance improvement data required by all agencies and regulatory entities, including program indicators and outcomes for the clinical program, apheresis program, and cellular therapy processing
  • Helps identify opportunities for the delivery of care based on analytical findings
  • In conjunction with the research specialists, completes and submits outcomes reporting forms for the Center for International BMT Research (CIBMTR)
  • Writes reports for quality and process improvement meetings for review by program management
  • Uses knowledge of the database to extract data and generate required reports and queries for statistical analyses in varying formats as requested
  • Analyzes transplant information for governmental agencies, physicians, managed care organizations, research studies, etc. by entering raw data into a computer, organizing and manipulating data, collecting data, consulting with team members, and generating graphs and charts
  • Prepares reports, presentations, and other documents as instructed
  • Maintains transplant and cellular therapy database
  • Reviews and audits database on a regular basis to ensure accuracy of data
  • Makes corrections and additions to database records as required
  • Fulltime
Read More
Arrow Right

Transplant and Cellular Therapy Quality Coordinator

Location
Location
United States , Park Ridge
Salary
Salary:
41.10 - 61.65 USD / Hour
advocatehealth.com Logo
Advocate Health Care
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor of Science Degree in Nursing or other healthcare related bachelors degree
  • 2-3 years of clinical practice quality management in a hospital setting or health related setting (Oncology/BMT preferred)
  • Knowledge in quality improvement activities and use of current evidence based practice
  • Experience in the use of quality management software
  • Proficient in statistical application and performance analysis
  • Proficient in spreadsheet, word processing, database, and graphic software
  • Proficient in evidence based practice, critical thinking, statistical knowledge, analytical skills
  • Excellent interpersonal skills with the ability to interact with a wide variety of healthcare individuals and teams
  • Effective written and verbal communication skills
  • Excellent organizational and prioritization skills
Job Responsibility
Job Responsibility
  • Recognizes changes in clinical situations, evaluates, and implement changes to the Standard Operating Procedures and contributes to the design and collection of data for required transplant reporting
  • Facilitates monthly BMT Quality meetings, analyzing and managing all the required data to be reported at the meeting
  • Participates in quality management activities to improve the quality of the bone marrow transplant program, following Foundation for the Accreditation of Cellular Therapy (FACT)
  • Actively participates in the quality improvement and quality management program activities including FDA, FACT, NMDP, CIBMTR
  • Participates in preparations for accreditations not limited to Foundation for the Accreditation of Cellular Therapy (FACT), Center for International Blood and Marrow Transplant Research (CIBMTR), National Marrow Donor Program (NMDP) Be the Match, Illinois Department of Public Aid, and various insurance groups
  • Works with hospital's legal and risk management departments as needed to ensure patient safety and accurate reports of transplant events and the development of program forms, SOPs and consents used for treatment
  • Participates in abstracting internal and external data used to develop departmental flow sheets and information graphs for educational presentations and required regulatory documentation
  • Participate in Standard Operating Procedures management
  • Uses current evidence to analyze data and develop recommendations and strategies to address complex issues and identify opportunities for improvement
  • Demonstrates appropriate critical thinking and effective communication skills to engage in collaborative relationships and involve stakeholders and other members of the team
What we offer
What we offer
  • Paid Time Off programs
  • Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
  • Flexible Spending Accounts for eligible health care and dependent care expenses
  • Family benefits such as adoption assistance and paid parental leave
  • Defined contribution retirement plans with employer match and other financial wellness programs
  • Educational Assistance Program
  • Parttime
Read More
Arrow Right

Transplant and Cellular Therapy Data Management Associate

Data Management responsibilities involve the collection and reporting of transpl...
Location
Location
United States , Park Ridge
Salary
Salary:
26.55 - 39.85 USD / Hour
advocatehealth.com Logo
Advocate Health Care
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Associate degree or equivalent
  • 3+ years experience in health care setting and/or research
  • Proficient computer and internet skills
  • Type 50 -60 words per minute preferred
  • Able to utilize several soft-ware packages
  • Ability to create spread sheets, power point, posters
  • Have analytical skills and be able to interpret data
  • Be familiar with the tools and methodology needed for successful quality control
  • Basic comprehension of medical oncology
  • Ability to travel throughout the LGH campus and to off campus offices as needed
Job Responsibility
Job Responsibility
  • Data Management responsibilities involve the collection and reporting of transplant patient clinical and outcomes data
  • the collection and reporting of patient data for clinical trials, following established sponsor protocols and procedures
  • Use multiple complex databases and Web-based systems, including the electronic medical record (EMR) and electronic data capture systems
  • Extract, analyze and enter the relevant data in a timely and accurate manner in to the CIBMTR
  • Maintain transplant databases and organize study records that serve as the basis for paper and electronic CRFs
  • Continue to update training in the proper use of FormsNet, CIBMTR web-based application and the National Marrow Donor Program (NMDP) forms
  • Tracks down long-term follow-up information on transplant patients who are no longer receiving active treatment
  • Ensure that source documents clearly supporting data reported are organized and readily accessible per regulatory review or sponsor requirements and site procedures
  • Communicates needed scheduling of participants on active treatment and in follow-up as it relates to data collection at protocol defined time points and site procedures
  • Data Manager participates and communicates activities related to regulatory operations and compliance, including bi-monthly reviews/audits of updates to protocols, completion of tracking tools, collection of documentation to support the Institutional Review Board (IRB) submissions and completion of forms for the IRB
What we offer
What we offer
  • Paid Time Off programs
  • Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
  • Flexible Spending Accounts for eligible health care and dependent care expenses
  • Family benefits such as adoption assistance and paid parental leave
  • Defined contribution retirement plans with employer match and other financial wellness programs
  • Educational Assistance Program
  • Parttime
Read More
Arrow Right

Transplant and Cellular Therapy Data Management Associate

Location
Location
United States
Salary
Salary:
26.55 - 39.85 USD / Hour
advocatehealth.com Logo
Advocate Health Care
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Associate degree or equivalent
  • 3+ years experience in health care setting and/or research
  • Proficient computer and internet skills
  • Type 50 -60 words per minute preferred
  • Able to utilize several soft-ware packages
  • Ability to create spread sheets, power point, posters
  • Have analytical skills and be able to interpret data
  • Be familiar with the tools and methodology needed for successful quality control
  • Basic comprehension of medical oncology
  • Ability to travel throughout the LGH campus and to off campus offices as needed
Job Responsibility
Job Responsibility
  • Data Management responsibilities involve the collection and reporting of transplant patient clinical and outcomes data
  • the collection and reporting of patient data for clinical trials, following established sponsor protocols and procedures
  • Use multiple complex databases and Web-based systems, including the electronic medical record (EMR) and electronic data capture systems
  • Extract, analyze and enter the relevant data in a timely and accurate manner in to the CIBMTR
  • Maintain transplant databases and organize study records that serve as the basis for paper and electronic CRFs
  • Continue to update training in the proper use of FormsNet, CIBMTR web-based application and the National Marrow Donor Program (NMDP) forms
  • Tracks down long-term follow-up information on transplant patients who are no longer receiving active treatment
  • Ensure that source documents clearly supporting data reported are organized and readily accessible per regulatory review or sponsor requirements and site procedures
  • Communicates needed scheduling of participants on active treatment and in follow-up as it relates to data collection at protocol defined time points and site procedures
  • Data Manager participates and communicates activities related to regulatory operations and compliance, including bi-monthly reviews/audits of updates to protocols, completion of tracking tools, collection of documentation to support the Institutional Review Board (IRB) submissions and completion of forms for the IRB
What we offer
What we offer
  • Paid Time Off programs
  • Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
  • Flexible Spending Accounts for eligible health care and dependent care expenses
  • Family benefits such as adoption assistance and paid parental leave
  • Defined contribution retirement plans with employer match and other financial wellness programs
  • Educational Assistance Program
  • Parttime
Read More
Arrow Right

Cell Therapy Program Manager RN

The Cell Therapy Program Manager RN plays a vital role in the multidisciplinary ...
Location
Location
United States , Madera
Salary
Salary:
56.00 - 92.25 USD / Hour
valleychildrens.org Logo
Valley Children's Healthcare
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelors Degree required in Nursing (preferred) or Health Care Related Field OR Combination of equivalent experience and education (required)
  • RN - Registered Nurse License - CA-BRN - California Board of Registered Nursing (required)
  • BLS - Basic Life Support - AHA - American Heart Association (required)
  • California Drivers License - Other With an acceptable driving record (required)
  • Car Insurance - Other With minimum limits as required by state law. (required)
  • National Certification - Other National certification in area of specialty. (preferred)
  • Minimum three (3) years Clinical, leadership and/or project management experience. (required)
  • Must have leadership and project management abilities and extensive advanced knowledge of nursing or respiratory care principles, clinical practice, quality and healthcare systems.
  • Demonstrates proficiency in the skills and knowledge required to perform the job in specialty area.
Job Responsibility
Job Responsibility
  • Plays a vital role in the multidisciplinary Hematology, Blood and Marrow Transplant, and Cellular Therapy (HBC) team, providing expert nursing care for patients undergoing Bone Marrow Transplant (BMT) or CAR T-cell therapy.
  • Managing care for both allogeneic and autologous recipients, as well as donors, throughout complex treatment processes.
  • Serves as the primary contact for patients, families, and healthcare providers, facilitating communication and ensuring seamless coordination of care in both inpatient and outpatient settings.
  • Responsibilities include triaging patient inquiries, educating patients and families about treatment options and changes, and collaborating with the HBC team to optimize patient outcomes.
  • Dedicated to monitoring and supporting patients, ensuring they achieve their maximum health potential throughout their treatment journey.
  • Fulltime
Read More
Arrow Right

Sr. Director, Clinical Scientist

The Sr. Director, Clinical Scientist plays a pivotal role in shaping the clinica...
Location
Location
United States , Philadelphia
Salary
Salary:
Not provided
cabalettabio.com Logo
Cabaletta Bio Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Advanced degree (MS, Ph.D., Pharm.D., M.D., or equivalent) in a relevant scientific discipline preferred
  • 7+ years of clinical development experience within biotech, pharmaceutical, or academic settings, with demonstrated leadership in advancing programs through early and late-stage development
  • Cell and gene therapy experience—particularly in CAR-T or T-cell–based modalities—strongly preferred
  • autoimmune disease experience highly desirable
  • Deep understanding of T-cell biology, immunology, and translational science principles relevant to cellular therapy
  • Proven ability to author and critically review clinical protocols, study reports, and regulatory documents, ensuring scientific integrity and compliance with ICH-GCP and global regulatory standards
  • Demonstrated skill in analyzing complex clinical data, conducting literature reviews, and synthesizing insights to inform program strategy
  • Exceptional scientific judgment, attention to detail, and analytical rigor
  • Strong communication and collaboration skills, with the ability to influence and partner effectively across cross-functional teams, investigators, and external experts
  • Highly organized with the ability to manage multiple priorities in a fast-paced, evolving environment.
Job Responsibility
Job Responsibility
  • Serve as the clinical science lead for assigned CAR-T programs, partnering with the Medical Director on the design, execution, and interpretation of clinical studies across all phases of development
  • Author and oversee key clinical documents — including protocols, amendments, informed consent forms, investigator brochures, clinical study reports, and regulatory submissions (e.g., INDs, CTAs, DSURs, BLAs/MAAs)
  • Review, analyze, and interpret emerging clinical data (safety, efficacy, PK/PD) to identify trends and issues, ensuring timely resolution through cross-functional collaboration
  • Conduct literature and competitive landscape reviews to inform study design, data interpretation, and program strategy
  • Provide ongoing data review to ensure study conduct aligns with protocol, patient safety standards, and data integrity expectations
  • Collaborate with the Medical Monitor to ensure awareness of key safety and efficacy findings, supporting SAE review, narrative development, and safety governance activities
  • Lead or support governance activities, including preparation and presentation of materials for Development, Executive, and Scientific Steering Committees, as well as oversight of external boards (e.g., DSMB, adjudication committees)
  • Contribute to and present scientific and clinical data internally and externally (e.g., investigator meetings, scientific conferences, regulatory interactions)
  • Serve as the clinical science representative on cross-functional development and study teams, providing scientific and strategic input to ensure cohesive execution
  • Mentor study team members and contribute to vendor oversight to ensure consistency, quality, and scientific rigor across all clinical deliverables
What we offer
What we offer
  • health and retirement, PTO, and stock option plans
Read More
Arrow Right

Director, Clinical Scientist

The Director, Clinical Scientist plays a key role in supporting the clinical dev...
Location
Location
United States , Philadelphia
Salary
Salary:
Not provided
cabalettabio.com Logo
Cabaletta Bio Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Advanced degree (MS, Ph.D., Pharm.D., M.D., or equivalent) in a relevant scientific discipline preferred
  • 4-5+ years of clinical development experience within biotech, pharmaceutical, or academic settings, with demonstrated leadership in advancing programs through early and late-stage development
  • Cell and gene therapy experience—particularly in CAR-T or T-cell–based modalities—strongly preferred
  • autoimmune disease experience highly desirable
  • Deep understanding of T-cell biology, immunology, and translational science principles relevant to cellular therapy
  • Proven ability to author and critically review clinical protocols, study reports, and regulatory documents, ensuring scientific integrity and compliance with ICH-GCP and global regulatory standards
  • Demonstrated skill in analyzing complex clinical data, conducting literature reviews, and synthesizing insights to inform program strategy
  • Exceptional scientific judgment, attention to detail, and analytical rigor
  • Strong communication and collaboration skills, with the ability to influence and partner effectively across cross-functional teams, investigators, and external experts
  • Highly organized with the ability to manage multiple priorities in a fast-paced, evolving environment.
Job Responsibility
Job Responsibility
  • Serve as a key clinical science contributor for assigned CAR-T programs, partnering with the Medical Director and other Clinical Development team members to support study design, execution, and interpretation across all phases of clinical development
  • Lead or contribute to the preparation of key clinical documents — including protocols, amendments, informed consent forms, investigator brochures, clinical study reports, and regulatory submissions (e.g., INDs, CTAs, DSURs, BLAs/MAAs)
  • Conduct literature and competitive landscape reviews to inform study design, data interpretation, and program strategy
  • Provide ongoing data review to ensure study conduct aligns with protocol, patient safety standards, and data integrity expectations
  • Collaborate with the Medical Monitor to ensure awareness of key safety and efficacy findings, supporting SAE review, narrative development, and safety governance activities
  • Lead or support governance activities, including preparation and presentation of materials for Development, Executive, and Scientific Steering Committees, as well as oversight of external boards (e.g., DSMB, adjudication committees)
  • Contribute to and present scientific and clinical data internally and externally (e.g., investigator meetings, scientific conferences, regulatory interactions)
  • Serve as the clinical science representative on cross-functional development and study teams, providing scientific and strategic input to ensure cohesive execution
  • Mentor study team members and contribute to vendor oversight to ensure consistency, quality, and scientific rigor across all clinical deliverables
  • Maintain awareness of emerging scientific and regulatory trends in cell and gene therapy and autoimmune diseases to integrate innovations into development strategy
What we offer
What we offer
  • health and retirement
  • PTO
  • stock option plans
Read More
Arrow Right
New

Director, Clinical Scientist

The Director, Clinical Scientist plays a key role in supporting the clinical dev...
Location
Location
United States , Philadelphia
Salary
Salary:
Not provided
cabalettabio.com Logo
Cabaletta Bio Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Advanced degree (MS, Ph.D., Pharm.D., M.D., or equivalent) in a relevant scientific discipline preferred
  • 4-5+ years of clinical development experience within biotech, pharmaceutical, or academic settings
  • Cell and gene therapy experience—particularly in CAR-T or T-cell–based modalities—strongly preferred
  • autoimmune disease experience highly desirable
  • Deep understanding of T-cell biology, immunology, and translational science principles relevant to cellular therapy
  • Proven ability to author and critically review clinical protocols, study reports, and regulatory documents
  • Demonstrated skill in analyzing complex clinical data, conducting literature reviews, and synthesizing insights to inform program strategy
  • Exceptional scientific judgment, attention to detail, and analytical rigor
  • Strong communication and collaboration skills
  • Highly organized with the ability to manage multiple priorities in a fast-paced, evolving environment.
Job Responsibility
Job Responsibility
  • Serve as a key clinical science contributor for assigned CAR-T programs, partnering with the Medical Director and other Clinical Development team members to support study design, execution, and interpretation across all phases of clinical development
  • Lead or contribute to the preparation of key clinical documents — including protocols, amendments, informed consent forms, investigator brochures, clinical study reports, and regulatory submissions (e.g., INDs, CTAs, DSURs, BLAs/MAAs)
  • Review, analyze, and interpret emerging clinical data (safety, efficacy, PK/PD) to identify trends and issues, ensuring timely resolution through cross-functional collaboration
  • Conduct literature and competitive landscape reviews to inform study design, data interpretation, and program strategy
  • Provide ongoing data review to ensure study conduct aligns with protocol, patient safety standards, and data integrity expectations
  • Collaborate with the Medical Monitor to ensure awareness of key safety and efficacy findings, supporting SAE review, narrative development, and safety governance activities
  • Lead or support governance activities, including preparation and presentation of materials for Development, Executive, and Scientific Steering Committees, as well as oversight of external boards (e.g., DSMB, adjudication committees)
  • Contribute to and present scientific and clinical data internally and externally (e.g., investigator meetings, scientific conferences, regulatory interactions)
  • Serve as the clinical science representative on cross-functional development and study teams, providing scientific and strategic input to ensure cohesive execution
  • Mentor study team members and contribute to vendor oversight to ensure consistency, quality, and scientific rigor across all clinical deliverables
What we offer
What we offer
  • health and retirement
  • PTO
  • stock option plans
  • Fulltime
Read More
Arrow Right