Stanford University is seeking a Quality Assurance Manager (Clinical Manufacturing Quality Assurance Analyst 3) to direct and oversee quality system processes and procedures including, but not limited to Validation Master Plan, Audit Program, Document Management, Deviations, CAPA, and Change Control, and to provide quality assurance oversight of the Quality Systems function for the Laboratory for Cell and Gene Medicine (LCGM).
Provide technical expertise to direct quality compliance between process development, manufacturing, and regulatory affairs for the LCGM.
Provide leadership and represents Quality Assurance on cross-functional project teams evaluating new quality processes or systems for Phase I/II GMP operations.
Provide leadership and oversight for continuous process improvement as new issues are detected, new knowledge becomes available, or change in regulation that add greater reliability, compliance, efficiency, and drive change.
Direct and oversee inspection readiness activities and investigations to resolve quality issues. Provide technical and quality assessment expertise to support discrepancy resolution and investigations.
Manage evaluation and approval of quality system documentation including but not limited to deviations, change control reports, and document changes for compliance requirements (SOPs, specifications, test methods, etc.).
Provide technical expertise and creativity in defining course of actions related to new processes, deviations, and investigations that may impact multiple functions in the organization.
Technical lead and project manager on process audits of vendors, contract manufacturers, contract laboratories, and quality systems for cGMP compliance to confirm all compliance standards are being met. Results of audits may require modification of process, updating procedures, or other corrective actions.
May manage two or more quality assurance staff in the day-to-day operations for functional area(s) of responsibility. Responsible for hiring and retaining staff, career coaching, personal development for direct reports and accountable for the performance of employees. Ensure work completion within schedule and constraints. Translate strategy to provide direction to own area. * - Other duties may also be assigned DESIRED QUALIFICATIONS:
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree and eight years' experience or Advanced degree and five years relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Advanced experience applying multidisciplinary scientific principles and practices to provide technical leadership and influence experimental design and coordinate laboratory activity
Extensive experience with Quality Assurance systems and processes.
Expert knowledge and technical understanding of the manufacture of Cellular Therapeutics and testing.
Extensive experience in reviewing cGMP/GLP related documents (SOPs, protocols, batch records, technical reports, etc.)
Full knowledge of GMP/ ISO compliance and quality systems.
Strategic planning, leadership, and negotiation skills, and the ability to develop and present training materials to large groups
Experience leading and/or managing technical professionals.
Experience providing technical leadership on complex projects, including developing processes and procedures.
Demonstrated resolution of complex issues in creative and effective ways
Proven ability to work under tight deadlines and pressure in a composed manner
Ability to communicate effectively, both verbally and in writing. Ability to influence and advocate course of action of research project.
Works effectively by encouraging collaboration and building productive partnerships across departments
Demonstrates thorough grasp of operational issues and performance standards for own area including key performance metrics
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. * - 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 the job.
Employee must perform tasks that require the use of personal protective equipment, such as safety glasses and shoes, protective clothing and gloves, and possibly a respirator.
May require working in close proximity to blood borne pathogens.
May at times require the employee to work with or be in areas where hazardous materials and/or infectious diseases are present.
May be exposed to high voltage electricity, radiation or electromagnetic fields, lasers, noise > 80dB TWA, Allergens/Biohazards/Chemicals, confined spaces, working at heights
May require extended or unusual work hours based on research requirements and business needs. Additional Information
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, 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.