What are the responsibilities and job description for the Head of Quality Assurance position at University of California San Francisco?
Applies extensive knowledge of healthcare industry regulatory affairs concepts to substantial projects of large scope and high degrees of complexity. May be a lead or resource in a specialty discipline. In particular, the Head of Quality Assurance (QA) ensures compliance with FDA regulations for Good Tissue Practice (GTP) and Good Manufacturing Practice (GMP) within the UCSF Human Islet and Cellular Transplantation Facility (HICTF). In addition, the Head of QA helps develop appropriate quality programs and standard operating procedures (SOPs) for process development activities and regulatory filings in support of early phase academic trials.
These efforts are led by the UCSF Experimental Cellular Therapy Group within the Department of Laboratory Medicine and involve widespread collaborative efforts across the University and partner institutions including the Department of Surgery, the Diabetes Center, the Department of Neurosurgery, the UCSF Living Therapeutics Initiative (LTI), the Gladstone-UCSF Institute of Genomic Immunology (GIGI), the Innovative Genomics Institute (IGI), the Weill Neurohub, Stanford University, the California Institute of Regenerative Medicine (CIRM), and the Parker Institute for Cancer Immunotherapy (PICI). In addition, activities support a number of exciting academic/industry partnerships for the UCSF including partnerships with Thermo/Patheon, Multiply Laboratories, and Arsenal Biosciences.
These efforts support a wide range of experimental cellular therapy development and manufacturing activities focusing on regulatory T cells, anti-cancer T cell therapy, CRISPR-Cas9-modified T cell therapies, and human stem cell-based therapies. The focus of the group is on first-in-human phase 1 clinical trials. We do not perform standard of care cellular therapy activities, such as hematopoietic stem cell transplants, which are handled by other UCSF facilities. You will work in close collaboration with the regulatory affairs, manufacturing, operations, and QC groups.
These efforts are led by the UCSF Experimental Cellular Therapy Group within the Department of Laboratory Medicine and involve widespread collaborative efforts across the University and partner institutions including the Department of Surgery, the Diabetes Center, the Department of Neurosurgery, the UCSF Living Therapeutics Initiative (LTI), the Gladstone-UCSF Institute of Genomic Immunology (GIGI), the Innovative Genomics Institute (IGI), the Weill Neurohub, Stanford University, the California Institute of Regenerative Medicine (CIRM), and the Parker Institute for Cancer Immunotherapy (PICI). In addition, activities support a number of exciting academic/industry partnerships for the UCSF including partnerships with Thermo/Patheon, Multiply Laboratories, and Arsenal Biosciences.
These efforts support a wide range of experimental cellular therapy development and manufacturing activities focusing on regulatory T cells, anti-cancer T cell therapy, CRISPR-Cas9-modified T cell therapies, and human stem cell-based therapies. The focus of the group is on first-in-human phase 1 clinical trials. We do not perform standard of care cellular therapy activities, such as hematopoietic stem cell transplants, which are handled by other UCSF facilities. You will work in close collaboration with the regulatory affairs, manufacturing, operations, and QC groups.
Department Description
The Department of Laboratory Medicine at the University of California, San Francisco is a leader in cellular therapy research, training, and patient care. Faculty in the department are involved with a wide variety of standard of care and experimental cellular therapy applications including hematopoietic stem cell transplant, regulatory T cell therapy for autoimmune disease and solid organ transplant, anti-cancer T cell therapies, and mesenchymal stromal cell therapy. You will be situated within the larger cellular therapy community at UCSF, which is undergoing a period of rapid expansion.
Required Qualifications
- Bachelor's degree in clinical or related area, and / or equivalent combination of experience / training.
- 5 plus years of Clinical Research or Drug Development experience
- Advanced skills in written and verbal communications, with the ability to convey highly-complex technical information, education, and instructions in a clear and concise manner, and to produce high-quality reports, documentation, presentations, and educational materials.
- Advanced knowledge of the methods, tools, and practices involved with regulatory compliance.
- Strong knowledge and understanding of compliance and regulatory standards across the healthcare industry or in-depth knowledge within a specialty area.
- Advanced organizational and project management skills, with the ability to lead a team, prioritize tasks, and see projects through from inception to completion on schedule.
- Advanced interpersonal skills for collaborating effectively with managers and staff at all levels and across the organization, and with representatives of external regulatory agencies. Skills in coaching and mentoring staff.
- In-depth ability to collaborate effectively with senior staff and management across departments, providing advice and counsel on complex regulatory issues of functionality, efficiency, and program development.
- Knowledge of Code of Federal Regulations including current Good Manufacturing Practices and Good Tissue Practices as they relate to cellular therapies and Investigational New Drugs
- Knowledge of quality assurance and quality programs
Preferred Qualifications
- Advanced degree in related field
License/Certification
- Preferred - Clinical Laboratory Scientist (CLS)
About UCSF
The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world’s leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.
Pride Values
UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence – also known as our PRIDE values.
In addition to our PRIDE values, UCSF is committed to equity – both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available at diversity.ucsf.edu
Join us to find a rewarding career contributing to improving healthcare worldwide.
In addition to our PRIDE values, UCSF is committed to equity – both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available at diversity.ucsf.edu
Join us to find a rewarding career contributing to improving healthcare worldwide.
Equal Employment Opportunity
The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Organization
Campus
Job Code and Payroll Title
006531 REGL AND CMPLNC HC SPEC 4
Job Category
Professional and Managerial
Bargaining Unit
99 - Policy-Covered (No Bargaining Unit)
Employee Class
Career
Percentage
100%
Location
Mission Bay (SF)
Shift
Days
Shift Length
8 Hours
Additional Shift Details
Limited or Contract End Date NA Work days & hours: M-F 8am-5pm with occasional weekends
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