The Associate Director of Quality Assurance (AD-QA; RTM1) ensures 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 cell and gene manufacturing facility that provides regulatory, quality, 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.
Provide strategic planning for own work group; participate with senior managers in higher level strategic planning. Communicate operational objectives and assignments and delegate to staff.
Manage the daily operations of an assigned area(s) which include recruiting, hiring, training, developing evaluating and setting priorities of staff, coordinate business, technical, and educational activities for direct reports.
Oversee interdepartmental activities, projects and efforts by applying advanced technical and professional knowledge. Serve as the initial managerial escalation point for problems from clients and other staff.
Manage project budgets, schedules, and resources. Oversee preparation of periodic financial and technical reports and operating plans.
Interface with clients to determine project requirements. Establish service level agreements with clients.
Monitor scientific, engineering, and/or technology trends and evaluate emerging technologies to recommend for adoption and implementation.
Oversee budget and schedule for large programs and/or multiple projects.
Negotiate with internal departments and external agencies with authority to commit resources and effort.
Recommend the adoption of emerging technologies and the development of new methods and approaches.
Liaise with senior management and cross-functional areas and schools. Serve as a liaison to external organizations.
Supervise other staff, including hiring, performance management, and related duties, in addition to providing instruction on complex techniques and direction on projects.
Communicate and implement policies, procedures, best practices, recommendations and guidelines compliance with established University administrative policies and procedures.
* - Other duties may also be assigned
Advanced degree in biology or other related field.
Knowledge of: Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), FACT and other regulatory requirements.
Experience with cGMP manufacturing of Phase I/II clinical products.
Experience with development of functional quality systems for cGMP compliant manufacturing for cell and gene therapies.
Demonstrated success and experience in Quality Assurance Systems and Operations management, implementation and oversight
At least 5 years of management experience including hiring, supervising, appraising employees. Matrix management experience desirable.
Experience with Quality Management Systems (QMS)
Experience with software as Microsoft Excel, Word, PowerPoint, Adobe Acrobat.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree and five years of relevant experience, or combination of education and relevant experience. Advanced degree may be required.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Experience leading or overseeing the work of technical staff.
Understanding of relevant scientific, engineering, or technical disciplines.
Ability to problem solve.
Ability to synthesize and articulate technical and scientific methodologies, specifications, and information.
Experience leading scientific, engineering, or technical research projects or programs.
Knowledge of emerging technologies, trends, methodologies, and resource management principles.
Ability to work and communicate effectively with others.
Strong customer relationship and consensus building skills.
Ability to influence and establish effective working relationships in a diverse environment.
Ability to resolve issues quickly and make decisions that meet university objectives in a collaborative culture.
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.
Additional PHYSICAL REQUIREMENTS: (remove if none)
May require extended hours, evenings and weekends.
Location: School of Medicine, Stanford, 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, 12000 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 is an equal empl...oyment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stanford also welcomes applications from others who would bring additional dimensions to the University’s research, teaching and clinical missions.