Director, Operations, Compliance and Regulatory Affairs

Job description

Director, Operations, Compliance and Regulatory Affairs
University of California Los Angeles

Requisition Number: 32815
Salary: $5,167 - $13,233 monthly

Position Description:
As a member of the Broad Stem Cell Research Center's senior leadership team, the director of operations, compliance and regulatory affairs oversees four of the Broad Stem Cell Research Center's (BSCRC) primary functional areas: Technical Operations, Facilities, Regulatory and Compliance.

This position manages complex operations across multiple buildings including Food and Drug Administration (FDA) compliant pre-clinical Good Tissue Practice (GTP) and clinical Good Manufacturing Practice (cGMP) laboratories critical for clinical research; research laboratories and core services for microscopy, sequencing, flow cytometry, animal radiation, biological, chemical, engineering and computational research. Responsibilities include maintaining infrastructure, building systems and services. This position establishes, maintains and monitors safety and security programs to meet federal, state, and local regulations. This position must establish and maintain operating policies and procedures, manage building modifications and equipment installation, and manage facilities support staff.

The position leads diverse projects from start to finish, including creating multi-year project plans, and overseeing multi-million dollar project budgets. This position drives the diligence and vendor qualification process to enable testing and purchase of cutting edge technical equipment, as well as strategic assessment of service contracts. The position leads negotiations with vendors and coordinates purchases with partners across campus. This position is responsible for all details of complex installation, implementation, and maintenance projects.

The incumbent provides key operational, administrative and financial oversight for BSCRC Core Facilities. This includes developing, monitoring and updating budgets, and planning for regular equipment updates and replacement. The director also creates strategic plans, and updates staffing, equipment, IT and other aspects of operations in response to the changing needs of the Center and its user base. The position oversees purchasing using grant funding, reconciliation and internal auditing, as well as the development of policies and procedures and maintenance of pertinent files and required records.

Additionally, this position directs support for compliance activities within the BSCRC as well as under the auspices of the Vice Chancellor of Research (VCR), such as UCLA's Human Pluripotent Stem Cell Research Oversight (hPSCRO) committee. The hPSCRO reports directly to the VCR and applies State, national and international legal, policy, and ethical standards in the review of all campus research with human pluripotent stem cells or progenitor cells, including research with human and non-human animal subjects. The position also oversees the quality assurance and compliance activities the BSCRC undertakes on behalf of the translational and clinical projects in its pipeline, including review of document management systems, inventory management, and batch records. Finally, this position oversees regulatory affairs for translational and clinical projects, including preparation of submissions to the FDA and response to audits by sponsors or other state, federal or international agencies.

The incumbent is expected to develop and maintain close working relationships with senior personnel across the university, including Deans, Department Chairs, and senior staff. This position works closely with UCLA Environmental Health and Safety and the Institutional Biosafety Committee to ensure a comprehensive effective approach to managing safety and security in BSCRC facilities. This position is the primary contact with UCLA Facilities Management at the Organization level. Additionally, this position must interact with state and federal agencies including responding to audits.

For full application instructions and position description, please visit:

The University of California is an Equal Opportunity/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, age or protected veteran status. For the complete University of California nondiscrimination and affirmative action policy, see: UC Nondiscrimination & Affirmative Action Policy,

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Job No:
Posted: 10/22/2020
Application Due: 11/13/2020
Work Type: Full Time