Associate Director, Animal Welfare - Hybrid

Merck•South San Francisco, CA

3d•Hybrid

About The Position

The Associate Director of Animal Welfare Quality Assurance will lead all administrative and operational functions of our company's Research Laboratory Institutional Animal Care and Use Committee (IACUC) in South San Francisco and participate in the continued development, implementation and oversight of the post-approval monitoring program. The individual will support quality improvement activities to promote research integrity across all research sites and ensure that the research carried meets both statutory, regulatory, and company ethical obligations.

Requirements

Bachelor's degree or equivalent in scientific related field required. Master's Degree preferred.
CPIA – Certified Professional in IACUC Administration preferred.
A minimum of 5 years of experience in the laboratory animal field.
Experience of Institutional Animal Care and Use issues and animal welfare.
Research compliance monitoring experience an asset.
Knowledge of Federal Laws, regulations, and procedures pertaining to the care and use of research animals, and the Guide for the Care and Use of Laboratory Animals.
Ability to collaborate with colleagues and engage stakeholders.
Adaptability
Administration Management
Administrative Leadership
Animal Ethics
Animal Welfare
Audit Management
Business Management
Compliance Investigations
Compliance Reviews
Corporate Ethics
Deviation Management
Global Program Development
Good Manufacturing Practices (GMP)
IACUC Protocols
IS Audit
Laboratory Animal Medicine
Leadership
Leadership Training and Development
Project Leadership
Project Risk Assessments
Protocol Review
Quality Assurance Systems
Quality Oversight
Quality Risk Management

Responsibilities

Provide day to day management and oversight of the animal use protocol review process using a web-based protocol tracking system for submission, and interfacing with IACUC members and investigators.
Serve as the primary contact for the principal investigators for questions related to the protocol review process.
Act as a resource for investigators on issues relating to the regulatory requirements for the use of animals in research
Plan and coordinate IACUC meetings.
Prepare the IACUC Meeting Agenda and accurately record IACUC Meeting actions.
Prepare semi-annual program reviews by the IACUC.
Conduct initial administrative and compliance review of all submitted protocols and amendments and use professional knowledge to assess completeness.
Assist investigators in preparation of animal procedure statements and/or responses to requests or revisions made the IACUC.
Maintain all protocol records, IACUC minutes, semi-annual program reviews, AAALAC program descriptions and correspondence.
Report results and findings of the facility inspections to the IACUC and prepare the semi-annual report for the Institutional Official.
Ensure that IACUC appointment letters are current for all required positions.
Discuss with laboratory and research staff to ensure that protocols and approved procedures are being followed and that research personnel performing the procedures have been appropriately trained and are approved by the IACUC to participate in research projects.
Review in-life procedures, records and other forms of documentation to further ensure that protocols and procedures are being conducted as approved in the IACUC protocols. This may include, but is not limited to: animal health records, procedure records, anesthesia records, post-operative monitoring records, drug inventories and/or daily husbandry logs.
Report findings as well as recurrent, program-wide issues to the IACUC.
Support routine and/or ad hoc requests for data trending & metrics and analysis.
Plan, initiate, conduct and lead vendor assessments & audits.
Promptly report significant compliance issues to the Animal Welfare team and to the IACUC.
Ensure tracking and completion of audit findings and reports.
Support our company's Research Laboratory Quality Assurance Animal Welfare business operational activities as needed.