Quality Manager

About Loyal

Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. In other words, our mission is to help dogs live longer, healthier lives.

We've already achieved significant milestones on our path to gaining FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track to bring the first product to market in 2025.

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

We're seeking an experienced Quality Manager to support our Clinical and CMC teams to help bring the first FDA approved longevity drug to market.

You will be responsible for the quality oversight of cGCP and cGMP activities across product teams and will support the development and implementation of the Loyal Quality System.

This role requires leadership, strong interpersonal and communication skills, and dynamic / flexible thinking to the application of regulatory requirements in a rapidly changing environment.

You will be reporting to our Director of Quality - Amanda Koperski.

About you:

• Bachelor's degree required with a specialization in science, engineering, or other health related field required. Quality certifications are a plus, but not required.
• Minimum of 3+ years experience with clinical studies, pharmaceutical manufacturing, laboratory testing, or quality systems (animal health or human therapeutics).
• Knowledgeable in 21 CFR 58 (GLP), VICH GL9 (GCP), 21 CFR 210/11 (GMP) and solid understanding of industry best practices.
• Comfortable applying risk management techniques to processes, decisions, and data.
• Communicate quality requirements and mentor team members in a relatable way.
• Enjoy thinking creatively, anticipating challenges, and developing innovative solutions to complex problems.
• Have a keen eye for detail and enjoy immersing yourself in technical data review.
• Familiarity with Google Workspace applications (e.g., Sheets, Slides, etc.).
  
  

Your daily work will include:

• Represent the Loyal Quality function on project teams. Develop and foster strong relationships with laboratories, CDMOs, and other third parties providing cGxP services.
• Evaluate and qualify potential suppliers and service providers.
• Review and approve procedures, protocols, reports, master batch records, and other QA-controlled documentation.
• Support the development and implementation of Loyal quality system processes and procedures. Provide feedback on these systems to facilitate continuous improvement.
• Review batch records for lot disposition of clinical and commercial products, ensuring lots are released in compliance with applicable regulations.
• Facilitate, review, and approve investigations and associated CAPA.
• Train and mentor Loyal team members on quality related topics.
• Organize and maintain quality records.
• Support audit/inspection activities, as needed.
• Occasional travel to visit suppliers and service providers.
  
  

How you work and think:

• You thrive in a team-oriented culture.
• Self-starter who takes ownership and responsibility.
• Detail-oriented, disciplined, and happy to be working on a mix of the (mostly) fascinating and (also some) mundane.
• Professional and clear communicator who can distill the important information for relevant stakeholders no matter how complex the scenario.
• Growth mindset, value transparency and welcoming feedback.
  
  

Why you will love this role:

• You are comfortable adapting to change, and operating in a fast-paced, highly-regulated environment where you can drive innovation and lean into moonshots.
• Thrive in the opportunity to create Quality processes and tools that will evolve rapidly as Loyal grows.
• You are comfortable in navigating change and guiding the teams by clearly communicating overall direction.
• You will live in an environment where radical candor is embraced, while maintaining empathy and respect.
  
  

What you'll gain from this role:

• Enabling the approval/launch of first longevity drugs approved by the FDA.
• A working environment that is positive, kind, thoughtful, and full of some of the smartest people in the industry.
• Experience building process and doing impactful work.
  
  

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 🐶
• Annual company retreat at beautiful locations across the country (recently: Tahoe, Cape Cod)
• Competitive salary
• Company equity options grant for new hires
  
  

Salary range: $110k - $150k

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.