The Hematopoietic Cell Transplant and Cellular Therapy (HCTCT) Quality Assurance and Compliance Clinical Nurse Manager is responsible for managing a wide variety of activities to ensure compliance with federal, state, and local regulations, FACT/JC/FDA and other accreditation standards and institutional requirements. This position will oversee the compliance and quality assurance personnel responsible maintaining standards for FACT accreditation and program growth. Includes responsibility for the Cellular Therapeutics and Transplantation Laboratory (CTTL) quality assurance goals and quality improvement activities in the context of both standard of care and clinical research guidance. This position collaborates with the Laboratory Medical Director, Cellular Immunotherapy Administrative Director, Laboratory Technical Specialists, the Immune Effector Cell Therapy (IEC) Quality RN and BMT Quality RN as well as other institutional departments and outside facilities that play a role in cellular therapies.
- Majority of time spent in an office environment working at a computer.
- Hybrid position (on site and remote).
- Work may require standing and walking during observation of clinical practices.
- Potential exposure to biological hazards normally associated with a clinical patient area and processing laboratory.
Program Responsibilities
- Ensure compliance with all applicable state and federal regulations and with FACT, JC, and other accreditation standards as applicable.
- Collaborates with leadership in identification of current and future service needs and shares responsibility for meeting those needs.
- Participates in regularly scheduled Cell therapy and BMT weekly service rounds.
- Actively participate in the development of quality standards and quality management.
- Provide opportunities and support for staff development.
- Manage and participate in process improvement projects.
- Approve policies and procedures for the processing laboratory and clinical program.
- in conjunction with the BMT Clinical Quality Manager and perform CTTL investigations regarding failure or delay when warranted
- Participate in the onboarding of new cellular products with quality agreement reviews.
Personnel management
- Monitor compliance with policies and procedures.
- Provides opportunities for staff to participate in committees and projects impacting quality and compliance.
- Participates in regularly scheduled meetings to share status of the program and problem solve workflow and personnel concerns.
- Promotes interdisciplinary collaboration among all members of the HCTCT team.
- Review and follow up on Safety Reports and/or complaints in collaboration with BMT program director, cellular therapy nurse manager, and CTTL. Provide education and feedback to team members, when necessary, support development of corrective action plans and participates in root cause analysis when appropriate.
- Conducts annual performance appraisals for quality and compliance staff
- Implement corrective action according to hospital policy as needed with support of Nurse Director and/or Administrative Director
Operations management/administration and business
- Supports and participates in departmental and institutional committees including MGH Nursing and CCPO.
- Accountable for implementing hospital, departmental, research and all regulatory standards.
Professional development
- Identifies learning needs and goals and designs a plan to meet them.
- Attend and participate in professional educational activities in the fields of quality and cellular therapies and serve as a ‘subject matter’ expert.
- Participate in standard development activities in the field of cellular therapy through committee membership and interaction with professional organizations such as FACT and AABB
- Participates in MGH Leadership and development opportunities as available.
- Coordinate correspondence with outside agencies and accrediting bodies
Approximately 6 FTEs with opportunity for growth
Working with Nurse Director of Ambulatory Services align with department budget.
We offer an outstanding benefits packages to eligible employees including…
Medical, Dental and Vision insurance
Tuition Reimbursement
Generous paid time off
Subsidized MBTA pass (50% discount)
Resources for childcare and emergency backup care
Hospital paid retirement plan and tax-sheltered annuity plan
Employee “Perks” - enjoy discounts on tickets and passes for everything from ski resorts to museums to sporting events.
You contribute to our success! Every role has an impact on our patients' lives, and you can make a difference. We are looking for someone as dedicated as you to be a part of our team!
About Mass General Hospital
Mass General Hospital is a world-renowned hospital that provides the highest quality care to patients. We are a leader in medical research and education, and we are committed to delivering our employees with a rewarding and fulfilling career.
Required
- Bachelor of Science in Nursing, with a minimum of 3 years of relevant experience
- Experience in quality management.
- Proficiency in the use of computers and Microsoft Office
- Proven coordination, team, leadership, and service skills
Preferred:
- Certification in Quality (NAHQ, ASQ or equivalent) and/or 3 years professional experience within the field of Cellular Therapy
- Masters in nursing or other degree (MHA, MPH, etc…)
- Knowledge of FDA (GMP/GTP regulations), CLIA, OSHA, and DPH regulations as well as FACT, JC, and AABB accreditation standards.
- Displays advanced knowledge of all applicable regulations and QA concepts and practice
- Recognized as a quality assurance resource within own department
- Demonstrates effective, self sufficient communication skills, including peer-directed presentations
- Demonstrates ability to plan and execute appropriate test systems and validations
- Has ability to lead process improvement projects of moderate complexity and scope
- Familiar with federal, state, and local regulations, FACT, AABB, FDA and JC accreditation requirements
Primary Location
MA-Boston-MGH Main Campus
Work Locations
MGH Main Campus
Job
Nursing-Management
Organization
Massachusetts General Hospital(MGH)
Schedule
Full-time
Standard Hours
40
Shift
Day Job
Employee Status
Regular
Recruiting Department
MGH Cancer Center
Job Posting
Oct 23, 2024
