Associate Director, Quality Assurance

Location
California, United States
Posted
04 Dec 2020
End of advertisement period
02 Feb 2021
Ref
87925
Contract Type
Permanent
Hours
Full Time

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.

Learn more about our team here: https://med.stanford.edu/lcgm.html.

Duties include:

  • 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

DESIRED QUALIFICATIONS:

  • 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:

None

PHYSICAL REQUIREMENTS*:

  • 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 Information

  • Schedule: Full-time
  • Job Code: 4986
  • Employee Status: Regular
  • Grade: L
  • Department URL: http://pediatrics.stanford.edu/
  • Requisition ID: 87925

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