CMC Quality Manager, Analytical

About Loyal Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives. We've already achieved significant milestones on our path to earning FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track for FDA conditional approval within the next year. Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies. About the role The CMC Quality Manager, Analytical, provides quality oversight and technical leadership for analytical development and testing activities supporting veterinary pharmaceutical products under FDA Center for Veterinary Medicine (CVM) guidance. This role ensures that analytical methods, stability programs, and product testing are scientifically sound, validated, and compliant with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and applicable regulatory expectations. The ideal candidate combines deep analytical chemistry expertise with a strong understanding of veterinary drug development, CMC regulatory requirements, and data integrity principles. Your daily work will include Analytical Quality Oversight

• Provide quality oversight for analytical method development, qualification, validation, and transfer in support of veterinary drug substance and drug product programs.
• Review and approve analytical study protocols, validation reports, method transfer packages, and specifications.
• Ensure that analytical testing, release, and stability studies are executed under GMP/GLP conditions and in compliance with FDA and ICH/VICH guidelines.
• Partner with Analytical Development, QC, and Manufacturing to ensure accuracy, reliability, and consistency of analytical data.
• Support establishment of phase-appropriate specifications, stability-indicating methods, and control strategies aligned with regulatory expectations.

Regulatory & Compliance Responsibilities

• Ensure analytical activities comply with FDA-CVM, ICH, and VICH quality and data integrity requirements.
• Provide quality input for analytical sections of CMC documentation (e.g., INAD, NADA, VMF, and stability summaries).
• Participate in the preparation and review of regulatory submissions and responses to health authority questions.
• Support internal and external audits of analytical laboratories, contract testing organizations (CTOs), and contract manufacturing organizations (CMOs).
• Lead or assist in investigations (e.g., OOS/OOT results, deviations), ensuring root cause analysis, CAPA development, and timely closure.

Quality Systems & Documentation

• Author, review, and approve SOPs, technical documents, and quality records associated with analytical testing, method lifecycle, and data management.
• Maintain inspection readiness and ensure compliance of analytical documentation with company policies and regulatory standards.
• Support implementation and continuous improvement of the Quality Management System (QMS) related to CMC and analytical operations.

Contribute to risk assessments for analytical methods, materials, and laboratory processes. About you

• Bachelor's degree in a scientific discipline (Pharmaceutical Sciences, Chemistry, Veterinary Science, or related field).
• Minimum 5-7 years of relevant pharmaceutical industry experience, with at least 6 years in GxP QA roles.
• Broad understanding of drug substance and drug product development and manufacturing, analytical methods and testing, and quality incident management. Experience with solid dosage forms and/or veterinary drug products preferred.
• Demonstrated success working with external manufacturing partners (CDMOs).
• Strong knowledge of FDA CVM regulations, cGMP, and VICH guidelines applicable to veterinary products.
• Exceptional written and verbal communication skills.
• Ability to manage multiple projects and priorities in a fast-paced, remote work environment.
• Detailed eye for logistics and problem solving.
• Willing to work and comfortable in a fast-paced startup environment with a dynamic team.
• Familiarity with Google Workspace applications (e.g., Sheets, Slides, etc.) and electronic Quality Management Systems.
• Experience with international regulatory environments (EU, Canada, etc.) a plus.

Salary range: $110,000 - $160,000 Loyal benefits

• Full-coverage health insurance - medical, dental and vision - for you and your dependents
• $1,000 home office equipment stipend
• $1,200/year learning budget for books, courses, etc.
• $250/month wellness budget for gym, cleaners, spa, food, etc.
• All 3-day weekends are turned into 4-day weekends
• Unlimited vacation and paid holidays
• Paw-ternity leave - adopt a dog and get a day off with your new family member
• Competitive salary
• Company equity options grant for new hires

Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. Our values Lean into moonshots We don't settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have. Opportunity is at the intersection We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos. Expertise without ego Titles do not determine who has a voice. We work on hard technical problems and have a ton of fun while at it. Learning by doing Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes. Lead with context We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams to succeed. Empathy and respect for all life Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously. Apply tot his job Apply To this Job