Quality Assurance Compliance Officer at loyalhealth

, , United States -

Full Time

Start Date

Immediate

Expiry Date

11 Feb, 26

Salary

185000.0

Posted On

13 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System, GxP Requirements, SOP Development, Training Management, Compliance Oversight, Document Control, Audits Management, CAPA Systems, Regulatory Standards, Organizational Skills, Communication Skills, Project Management, Animal Health Knowledge, eQMS Experience, Attention to Detail, Team Collaboration

Industry

technology;Information and Internet

Description

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, manufacturing and clinical operations are high quality, and that any deviations from this are investigated and understood. The Quality Compliance Officer is responsible for maintaining and continuously improving the company’s Quality Management System (QMS) to ensure compliance with applicable regulations, standards, and internal policies. This role oversees the development, implementation, and management of Standard Operating Procedures (SOPs), company-wide training programs, and quality compliance activities that support operational excellence and regulatory readiness. The ideal candidate combines strong regulatory knowledge (animal health) with excellent organizational and communication skills and thrives in a dynamic, cross-functional environment. You will be reporting to our VP of Regulatory and QA. Your daily work will include: Quality Management System (QMS) Administration Maintain, monitor, and continuously improve the company’s eQMS in alignment with GxP (GCP, GLP, GMP) and ISO quality principles. Ensure eQMS documentation (e.g., SOPs, forms, work instructions, policies) is current, compliant, and effectively implemented across departments. Oversee document control processes, including drafting, reviewing, approving, and archiving quality documents. Lead periodic reviews and revisions of quality documents to ensure ongoing compliance and operational relevance. SOP Development and Management Identify gaps or new operational areas requiring formalized procedures; determine when new SOPs or updates are needed. Author, review, and approve SOPs in collaboration with functional area leaders. Ensure SOPs are clear, practical, and aligned with applicable regulations and internal best practices. Manage the SOP lifecycle, including version control, obsolescence, and communication of updates. Training and Compliance Administer the company’s training management system, ensuring all staff receive and complete required training on time. Develop and implement training programs for onboarding, GxP, SOPs, and compliance topics. Track and report training completion metrics and maintain accurate training records. Collaborate with department heads to identify training needs and continuous improvement opportunities. Quality and Compliance Oversight Support internal and external audits by ensuring readiness and compliance across documentation and processes. Coordinate corrective and preventive actions (CAPA) and ensure timely follow-up and closure. Monitor quality metrics and generate compliance reports for management review. Promote a culture of quality, integrity, and continuous improvement across the organization. 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 stakeholders (drug development, preclinical development, regulatory, project teams, company leadership, etc) and external stakeholders (CROs, CDMOs, other partners, consultants, regulatory authorities). Impact of work The Quality Compliance Officer 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 the partner. Team building/Culture requirements Communicate with context, as this helps teams understand the guard rails around the quality process and why it matters. Ensure timeline requirements for Quality are communicated and included in project planning. Maintain a high level of attention to detail to ensure documents subject to the Quality review are internally and externally consistent. Design a Quality Assurance Unit program and system that is fit for purpose in the current company and can scale to a foreseeable future. Be a kind and considerate team member, especially where quality reviews make life harder for collaborating teams in house. Startup mindset: work fast, low ego, comfortable with uncertainty, and collaborative. About you: Bachelor’s degree in STEM or related field or equivalent work experience. Minimum 5-10+ years of experience in quality assurance, compliance, or document control (animal health strongly preferred). Strong working knowledge of QMS principles, GxP requirements (especially GCP/GLP and GMP), and relevant regulatory standards (FDA, EMA, ISO 9001, VICH). Willing to familiarize yourself with regulatory practices in which you may not have experience. Experience with electronic Quality Management Systems (eQMS) and learning management systems (LMS). Track record of success and a broad understanding of current QA practices as they apply to animal health and quality assurance. In-depth knowledge of FDA-CVM and other international clinical research regulations. Proven experience in managing audits, inspections, and CAPA systems. Exceptional writing, organizational, and communication skills. Proven ability to manage multiple projects and deadlines in a regulated environment. Ability to influence cross-functional teams and drive a culture of quality and compliance. Salary range: $155,000 - $185,000 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.

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Responsibilities

The Quality Compliance Officer is responsible for building and leading quality assurance systems with a focus on FDA-CVM regulatory compliance. This role ensures high quality in drug development, manufacturing, and clinical operations while investigating any deviations.