Qa specialist [h1.location_city]

Director of Clinical QA

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

Responsible for building and leading cross-functional quality assurance systems across Loyal teams with an emphasis on FDA-CVM regulatory compliance for drug submissions and products. The work will ensure that all aspects of drug development and clinical operations are high quality, and that any deviations from this are investigated and understood.

You will be reporting to our VP of Regulatory and QA.

Your Daily Work Will Include :

Key areas of responsibility :

• Lead the design and execution of the Clinical Quality Assurance strategy to ensure GCP compliance across all studies.
• Oversee and manage the clinical audit program, including investigator site audits, vendor audits, and internal process audits.
• Develop, implement, and maintain policies, SOPs, and training programs to support compliance with global regulations (FDA, EMA, VICH-GCP, etc.).
• Partner with Clinical Operations, Regulatory, and other cross-functional teams to proactively identify and mitigate quality and compliance risks.
• Provide quality oversight of vendors and CROs to ensure adherence to contractual and regulatory obligations.
• Support clinical trial inspections (FDA, EMA, etc.) and lead preparation and response activities.
• Analyze audit trends and inspection findings to develop continuous improvement initiatives.
• Serve as the company's subject matter expert (SME) on GCP-related quality and compliance matters.
• Review all protocols, data and reports being generated under GLP / GCP. This includes data collection & interpretation. Prepare quality summaries as required.
• Manage and respond to adverse events (with clin ops) for drug products in the clinic and beyond.
• Lead, mentor, and develop a team of quality professionals.
• Help with training new regulatory hires or contractors as appropriate.
• Building a Quality Assurance Unit process and team as Loyal grows and requires expansive quality assurance infrastructure.
• Design a program and system that is fit for purpose in the current company and can scale to a foreseeable future.
• Build in assumptions around when there might be step changes in Quality approaches or requirements.
• Prepare for Quality aspects of Global expansion.
• Develop, implement, and manage systems to ensure consistency and quality across all Loyal teams. Examples :
• Research Ops / Dog Ops QA : Standard checklists / docs for study design, study startup, data review, study closeout, and final reports.
• People Ops QA : Standard checklist for new employees (science-based section, ops-based section).
• Supporting commercial recalls, adverse events, customer complaints.
• Being the face of the company for Clinical Quality matters when interfacing with regulatory authorities.

Levels of autonomy :

Impact of work :

Team building / Culture requirements :

About You :

Salary range : $175,000 - $200,000

Loyal Benefits :

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.