Director of Clinical QA

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

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. All sites that are to be used for GLP/GCP work should be audited prior to conducting regulated work. This includes development of GLP and GCP facility audit documents.
• 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

• For Quality aspects of in- house programs keep line leads, supervisor and company leadership informed of strategy and status, but with high autonomy to determine approach, request work be completed and request additional resources. 
• For building a Quality Assurance Unit process and team, high autonomy to design the program, need support and authorization from company leadership to implement (time, resources, backing for the cultural shift that might be required).
• Interact effectively with internal teams (drug development, preclinical development, regulatory, project teams, company leadership, etc) and external partners (CROs, CDMOs, other partners, consultants, regulatory authorities)

Impact of work

• The Director of Quality role ensures that in house and external programs are executed to an appropriate quality standard. 
• When working with external teams the role is to ensure that appropriate quality systems are implemented, even if that is not the preferred option for