The Laboratory for Cell & Gene Medicine (LCGM) at Stanford University is seeking an Associate Director of Quality Assurance to ensure compliance of the LCGM with all Federal and State regulations governing the manufacturing of cell and gene therapy products for clinical trials conducted under Investigational New Drug (IND) applications. The Associate Director will oversee the quality assurance activities related to manufacturing and release of clinical products; will ensure facilities and manufacturing operations are conducted according to current Good Manufacturing Practices (cGMP); will provide training and certification for staff; will control distribution, tracking and archiving of clinical materials and provide support for processes essential to the production of biotechnical products. The Associate Director will be part of the LCGM management team and will act as a liaison between LCGM and clinical and research investigators, other collaborators and vendors. The Laboratory for Cell and Gene Medicine (LCGM) is a ~25k ft2 multi-product biologics manufacturing facility that provides regulatory, quality systems, process development and manufacturing support to the School of Medicine, Lucile Packard Children's Hospital (LPCH) and Stanford Health Care (SHC) in developing innovative cell and gene-based therapies for clinical trials that treat disease and promote health in pediatric and adult patients.
Make decisions independently regarding projects, programs, and initiatives within confines established by management.
Clarify and resolve issues with substantial significance and impact, which may span multiple areas, using advanced technical and professional knowledge.
Monitor and evaluate completion of tasks and projects. Oversee interdepartmental activities and efforts.
Manage project budgets, schedules, and resources; lead planning activities for assigned area.
Oversee preparation of periodic financial and technical reports and operating plans.
Interface with customers to determine project requirements.
Select, develop, and evaluate personnel to ensure the efficient operation of the function.
Supervise other staff, including hiring, performance management, and related duties, in addition to instruction on complex techniques and direction on projects. * - Other duties may also be assigned
Understanding and savvy to implement Quality Assurance in an Academic cGMP setting. EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree plus five years of relevant experience, or combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Demonstrated experience leading and managing technical staff.
Demonstrated experience leading large projects or programs.
Demonstrated ability to work and communicate effectively with others. CERTIFICATIONS & LICENSES:
Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.
Occasionally sit, use a telephone or write by hand.
Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls. * - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
Location: School of Medicine, California, United States Schedule: Classification Level:
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
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Located between San Francisco and San Jose in the heart of Silicon Valley, Stanford University is recognized as one of the world's leading research and teaching institutions. Leland and Jane Stanford founded the University to "promote the public welfare by exercising an influence on behalf of humanity and civilization." Stanford opened its doors in 1891, and more than a century later, it remains dedicated to finding solutions to the great challenges of the day and to preparing students for leadership in a complex world. The University's thriving diverse community is comprised of nearly 7000 undergraduate students, 9000 graduate students, 2000 faculty members, 1900 postdoctoral scholars, and over 11,000 academic and administrative staff in seven schools including several interdisciplinary research centers and institutes. The campus spreads over 8000 contiguous acres and nearly all undergraduates live on campus. Stanford offers bachelor's and master's degrees in addition to doctoral degrees (PhD, MD, DMA and JD) plus a number of professional and continuing education programs and certifications. More at http://facts.stanford.edu and http://www.stanford.edu. Stanford University is an ...equal opportunity employer and is committed to increasing the diversity of its faculty. It welcomes nominations of and applications from women, members of minority groups, protected veterans and individuals with disabilities, as well as from others who would bring additional dimensions to the university’s research, teaching and clinical missions.