Associate Director, Animal Welfare Quality Assurance (IACUC)
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
The Associate Director of Animal Welfare Quality Assurance will lead all administrative and operational functions of the Institutional Animal Care and Use Committee (IACUC) in South San Francisco and Palo Alto and participate in the continued development, implementation and oversight of the post-approval monitoring (PAM) program. The individual will also provide support to the compliance review of research protocols and quality improvement activities across all Merck Research Laboratories (MRL) research sites.
- 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
- Participate in vendor assessments & audits.
- Promptly report significant quality issues to the IACUC
- Ensure tracking and completion of audit findings and reports.
- Support MRL Quality Assurance Animal Welfare business operational activities as needed
- Bachelor Degree or equivalent in scientific related field
- A minimum of 5 years of experience in the laboratory animal field
- 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
- Demonstrated self-starter and flexible
- Ability to raise potential risks/issues to management with courage and candor
- Excellent communication skills both written and spoken
- Advanced degree desirable (Master, PhD or DVM)
- Certified Professional in IACUC Administration (CPIA) an asset
- Post-Approval monitoring experience an asset
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Quality Assurance
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck