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Overview
The Quality Assurance Director will provide the Cell Manipulation Core Facility with direction and leadership in the development, implementation and auditing of Quality programs to support regulatory and accreditation compliance with applicable requirements (GMP/GTP/FACT/JC and other industry standards) as well as federal and state laws, and ensure that clinical and laboratory operations meet the highest quality standards set by the organization. This position will interface with both inter and intra institutional departments and industry sponsors, as well as regulatory and accreditation agencies. This position also interfaces with accreditation and regulatory auditors as well as with clinical research and industry sponsors to develop positive working relationships and ensure that compliant objectives for cell and tissue processing are understood and met. This position works extensively with both inter and intra institutional departments to ensure that compliant and safe processes and policies are developed for manufacturing, testing and infusion of cellular products.
This position oversees a group of quality specialists who carry out a variety of functions as part of the quality program including; clinical and laboratory quality assurance, quality control, and quality improvement activities in the context of both standard of care and clinical research treatments as well as with cellular product development and technology transfers.
The position oversees and is responsible for the compliant execution of the following key areas for the department. This list of key quality systems below is a snapshot and not limited to:
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
The Quality Assurance Director will provide the Cell Manipulation Core Facility with direction and leadership in the development, implementation and auditing of Quality programs to support regulatory and accreditation compliance with applicable requirements (GMP/GTP/FACT/JC and other industry standards) as well as federal and state laws, and ensure that clinical and laboratory operations meet the highest quality standards set by the organization. This position will interface with both inter and intra institutional departments and industry sponsors, as well as regulatory and accreditation agencies. This position also interfaces with accreditation and regulatory auditors as well as with clinical research and industry sponsors to develop positive working relationships and ensure that compliant objectives for cell and tissue processing are understood and met. This position works extensively with both inter and intra institutional departments to ensure that compliant and safe processes and policies are developed for manufacturing, testing and infusion of cellular products.
This position oversees a group of quality specialists who carry out a variety of functions as part of the quality program including; clinical and laboratory quality assurance, quality control, and quality improvement activities in the context of both standard of care and clinical research treatments as well as with cellular product development and technology transfers.
The position oversees and is responsible for the compliant execution of the following key areas for the department. This list of key quality systems below is a snapshot and not limited to:
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
Responsibilities
Additional Duties and Responsibilities:
Additional Duties and Responsibilities:
Qualifications
MINIMUM JOB QUALIFICATIONS:
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
SUPERVISORY RESPONSIBILITIES:
Gives direction to all Quality Assurance Specialists and provides guidance to others in close collaboration with CMCF’s Management Team.
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
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.
EEOC Poster
MINIMUM JOB QUALIFICATIONS:
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
SUPERVISORY RESPONSIBILITIES:
Gives direction to all Quality Assurance Specialists and provides guidance to others in close collaboration with CMCF’s Management Team.
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
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.
EEOC Poster
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