Sr. Quality Manager

Location
Stanford
Posted
May 26, 2017
Institution Type
Four-Year Institution


Stanford University

Sr. Quality Manager

Job Number:
75108

5/16/2017 RC Manager 2 (4933) Position number 00044606 Salary Range K Sr. Quality Manager Job Purpose

If you have experience with regulatory affairs and the protection of human or animal subjects in research, you may be the right match for this Sr. Quality Manager position in the Research Compliance Office (RCO). RCO is charged with ensuring that all aspects of the Human Research Protection Program (HRPP) and the Institutional Animal Care and Use Program (IACUP) comply with all applicable laws, regulations, and policies, including standards of excellence necessary for maintaining accreditation status. This position is core to Stanford's research compliance activities.

Under the direction of the Associate Director for Program Development, the Sr. Quality Manager will partner closely with Research Compliance Office (RCO) leadership to promote a culture of process improvement in support of RCO's mission. The incumbent will develop strategies to enhance efficiencies and streamline existing processes with an eye for consistency wherever possible, collaborate with staff to identify opportunity for improvements, and measure the quality and integrity of services delivered. In addition, the Sr. Quality Manager will be the steward of official documents and procedures to facilitate record management and document control. Other duties may include serving as an expert contact with research investigators and administrators; educating parties on relevant and emerging regulations, and supporting educational activities.

CORE DUTIES* Develop, implement, and manage process improvement to facilitate the review of human/animal research protocols in accordance with Stanford, federal, accreditation, and state policies and procedures.

Perform review of complex research protocols, including identifying problems and issues. Recommend, design, and conduct reviews as necessary to ensure improvements are implemented

Plan and coordinate monthly IRB/IACUC review and follow-up activities in order to drive consistency and streamlining effort throughout RCO. Advise on and support standardization and streamlining of processes wherever possible and appropriate, in line with best practices to ensure accuracy and compliance.

Serve as an expert liaison between the research investigator and the reviewer; educate parties on relevant and emerging regulations and related risk management issues.

Apply knowledge of federal, state, and local regulations, as well as university policies and practices, to ensure satisfactory compliance. Ensures HRPP and IACUP are in compliance with federal regulations, state laws, and Stanford policies. Manage official documents and procedures for easy updates, maintenance, and retrieval.

Provide assistance to management in preparation for accreditation and in various compliance and quality assurance activities. Advise RCO leadership on strategies for campus outreach and readiness, education and monitoring

Lead special projects or meetings on complex issues; participate in multifunctional teams, and assist in implementing solutions in the various RCO groups

May manage the work of other employees, recommend hiring or disciplinary actions, or provide coaching, training, and mentoring, as assigned.


*Other duties as assigned

MINIMUM REQUIREMENTS:

Minimum Education and Experience

  • Bachelor's degree and five years of relevant experience, or combination of education and relevant experience

Minimum Knowledge, Skills and abilities required of the position

  • Comprehensive knowledge of regulatory information regarding the use of human/animal participation in research and teaching
  • Demonstrated understanding of the principles of Human/Animal research protection standards
  • Strong knowledge of grants and contracts function
  • In-depth understanding of operational requirements pertaining to management and implementation of protocol process
  • Strong communication and presentation skills (verbal and written)
  • Demonstrated analytical skills
  • Direct IRB or IACUC experience, preferably with an AAHRPP or AAALAC accredited institution. Advanced knowledge of human subjects/animal protection regulations and best practices, as evidenced by certification (e.g., ability to obtain or retain IRB or IACUC professional )

Preferred:

  • Significant working knowledge of research procedures and terminology, medical terminology, clinical trials and research data management
  • Knowledge of medical/scientific areas such as gene transfer, HIV AIDS, stem cells, cellular biology, biosafety, health and safety, epidemiology

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.



Job: Compliance Legal

Location: Dean of Research
Schedule: Full-time
Classification Level:

To be considered for this position please visit our web site and apply on line at the following link: stanfordcareers.stanford.edu

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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