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Opportunity: Sr Manager of QA Cell Therapies (#26953) @ Dana-Farber Cancer Institute -- Boston, MA (US)
Submitted by Human Resources; posted on Monday, September 07, 2015
BACKGROUND
About Dana-Farber:
Located in Boston, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow's physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
RESPONSIBILITIES
Overview:
Dana-Farber Cancer Institute is accepting applications from experienced quality professionals for the position of Senior Quality Assurance Manager for hematopoietic stem cell transplantation and other cellular therapies. Dana-Farber Cancer Institute manages one of the largest stem cell transplant clinical and research programs in the U.S. and is dedicated to providing all necessary resources and support to ensure the highest possible quality and patient safety. The Senior Quality Assurance Manager will oversee the transplant and cell therapy clinical quality program and staff, collaborating closely with the cell processing quality team as well as other quality staff throughout multiple sites of care. The Senior Quality Assurance Manager ensures suitable regulatory compliance methodology and documentation, and ensures development, implementation and support for continuous quality and process improvement. As a key member of the clinical leadership team, will provide consultation and guidance to leadership and all staff involved with the care and coordination of patients in the program. Will provide advisory and informational support to administrative leadership and other institutional executives and officials relative to transplant and cellular therapy quality outcomes. This individual will educate all institutional staff as needed regarding quality standards and the operational methods necessary to comply with such standards. The Senior Quality Assurance Manager ensures full integration of the program's quality systems with the organization's patient safety and risk management enterprise, serves as the key quality contact for the program for other leaders in the institution, and will be expected to lead or support quality research and improvement initiatives internally and as a representative of the organization for national or multi-site quality projects.
Working closely with clinical staff, duties include oversight of the development, updating and dissemination of standard operating procedures for clinical practices that fall under regulatory control, for monitoring and reporting on stem cell transplantation and other cell therapy clinical key indicators, performing and managing responses to clinical process audits, and managing planned and unplanned deviation reporting and trend analysis. Will coordinate FACT, FDA, JC, AABB, and other relevant compliance reporting and reaccreditation and inspection readiness requiring a full understanding of all relevant quality standards; ensures that all regulatory and internal outcomes driven operating procedures are implemented and tracked. Will support clinical leadership in the development of treatment plans, consents and forms as needed to ensure structured clinical practices. Will be expected to participate contemporaneously in deviation and adverse event documentation and assessment and play a lead role in subsequent root cause analysis and corrective action. Will play a lead rolein the development of uniform training standards, procedures and documentation of competencies for all staff engaged in the coordination and care of transplant and cell therapy patients and donors.
Supervisory Responsibilities:
- 3 direct reports and a total direct and indirect group of 6 staff members.
- Manages the staff of the quality program, currently including Quality Improvement Managers, Quality Assurance/Quality Improvement Specialists and a Cord Blood collection team.
Patient Contact:
- Occasional direct patient contact and extensive familiarity with cases is a major aspect of this position.
Schedule:
- This is a full time position.
- On-call coverage is required in certain circumstances and will be scheduled well in advance. Hours are generally flexible, but long individual workdays may be needed during inspection preparation periods or for other organizational needs.
REQUIREMENTS
Minimum Job Qualifications:
Bachelors degree is required plus a minimum of 8 years experience in a quality management and regulatory affairs role. Relevant higher degree may off set up to two years of required experience. Previous clinical coordination or clinical care experience is required, preferably in an oncology clinical setting, blood bank/hematology support and/or in a marrow/stem cell clinical program. Successful supervisory experience is required.
Knowledge, Skills, And Abilities Required:
- Must have excellent English language reading, writing and verbal communication skills. Must have demonstrated ability to lead clinical practice teams to perform work in a compliant and quality focused manner. Must have demonstrated ability to embrace and leverage institutional cultural and knowledge strengths.
- Demonstrated ability to supervise well prepared staff working as a team to perform complex and challenging change management and quality improvement implementation.
- Must be knowledgeable of FACT, FDA, AABB, and JC regulations at a high level of expertise. Must have clinical database facility,both for reporting and for organizing information in a useful manner,and be competent in the use of institutional clinical information and health record systems.
TERMS
Job Family: Quality/Risk Mgm/Patient Sfty
Full/Part Time: Full-Time
Regular/Temporary: Regular
LOCALE
Location: 44 Binney St, Boston
HOW TO APPLY
Please apply directly online at http://www.dana-farber.org/Careers/Careers-at-Dana-Farber.aspx. Click Search Job Openings and use the Job ID number to quickly locate the appropriate job listing. Once you have located the desired job, click on the checkbox in the 'Select' column, and then click the 'Apply Now' button, located at the bottom of the screen.
DFCI Employees please apply directly through PeopleSoft Self Service. Sign on to PeopleSoft and navigate to Main Menu > DFCI Careers.
Job ID: 26953
Date Posted: 08/07/2015
POLICY
Equal Employment Opportunity
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.
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