Skills
Analytical Quality Assurance
Drug Substance Testing
GxP Data Integrity
About the Role
Loyal is a clinical-stage veterinary medicine company focused on longevity drugs for dogs. We’re building proactive therapies that target underlying drivers of aging to help delay disease and preserve quality of life as dogs get older.
We’re seeking a Principal Analytical QA Specialist to support analytical quality activities for drug substance workstreams as we advance toward FDA approval for our lead program.
Responsibilities
- Own and execute analytical QA oversight for drug substance testing, including review of analytical methods, specifications, and related quality documentation.
- Partner with analytical science and quality teams to ensure data integrity, compliance, and appropriate documentation across investigations, deviations, and change controls.
- Support validation/verification activities for analytical methods and ensure readiness for regulatory review.
- Review and approve analytical test documentation (e.g., protocols, reports, raw data packages) according to internal quality standards and applicable regulations.
- Contribute to continuous improvement by identifying risks, trends, and opportunities to strengthen analytical quality systems.
Requirements
- Extensive experience in analytical quality assurance within pharmaceutical or veterinary pharmaceutical development, with a strong focus on drug substance.
- Working knowledge of cGMP expectations, data integrity principles, and documentation practices for regulated environments.
- Experience supporting analytical method validation/verification, investigations, deviations, and change control processes.
- Strong attention to detail and ability to communicate quality decisions clearly across cross-functional teams.
- Experience preparing materials for regulatory interactions (e.g., FDA) is a plus.
Benefits
- Opportunity to help advance first-in-class veterinary longevity therapies.
- Work with a multidisciplinary, mission-driven team.
- Remote work across the United States.
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