Quality Control Manager

Merck•Millsboro, DE

22h•Hybrid

About The Position

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. The Quality Control Manager – Animal Testing is responsible for providing leadership, oversight, and regulatory compliance for in-vivo animal testing programs supporting product safety, potency, efficacy, and purity. This role ensures animal testing activities are executed in compliance with USDA veterinary biologics regulations, applicable animal welfare standards, and internal quality systems. The position serves as a key quality and technical leader, partnering closely with Animal Care, Quality Assurance, Quality Control, Supply Chain/Planning, and other cross-functional stakeholders to ensure compliant and reliable operations.

Requirements

Minimum of 5 years of experience in regulated animal testing or in-vivo testing environments.
Demonstrated leadership experience managing or influencing animal testing teams.
Strong working knowledge of USDA veterinary biologics regulations and expectations.
Ability to operate effectively in a highly regulated, inspection-ready environment.
Strong written and verbal communication skills and ability to work cross-functionally.

Nice To Haves

Experience supporting USDA CVB or equivalent regulatory inspections.
Familiarity with deviation investigations, CAPA, and change management processes.
Experience in pharmaceutical, biologics, or vaccine manufacturing environments.

Responsibilities

Lead and oversee in-vivo animal testing programs including safety, potency, efficacy, and purity testing.
Provide leadership, coaching, and development of animal testing staff; ensure training and qualification requirements are met.
Ensure all testing is conducted in accordance with approved protocols, SOPs, regulatory requirements, and animal welfare standards.
Review animal test records and data for accuracy, completeness, and compliance.
Lead and/or participate in investigations related to unsatisfactory, atypical, or out-of-trend results.
Author, review, and approve SOPs, protocols, and controlled documentation.
Serve as a subject matter expert during internal audits and regulatory inspections.
Oversee the department’s controlled substances program.
Promote a continuous improvement mindset by modeling MPS skills and behaviors.
Collaborate closely with the Animal Care Manager and cross-functional partners to deliver departmental objectives through shared accountability.