Director, Quality Systems and Compliance

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $180k - $220k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Loyal

WebsiteLinkedInAll Job Openings

51 - 200 employees

⚕️ Healthcare Insurance

🤖 Artificial Intelligence

☁️ SaaS

Healthcare Insurance • Artificial Intelligence • SaaS

Loyal is a comprehensive digital healthcare platform that integrates various touchpoints for patients and providers. Their solutions include data management, digital engagement, CRM campaigns, self-scheduling, and conversational AI, which are designed to optimize healthcare operations, improve patient engagement, and enhance care search and scheduling. Loyal focuses on making healthcare seamless by unifying provider and location data, managing reputation and directory listings, and offering robust machine learning and natural language processing capabilities to improve healthcare outcomes. The platform facilitates improved communication and retention through omni-channel engagement and feedback analysis, serving prominent healthcare organizations to streamline operations and drive better patient experiences.

📋 Description

• 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. • Own the design, administration, and continuous improvement of the electronic QMS, including validation status, user access, workflow configuration, and system health. • Maintain, monitor, and continuously improve the company’s eQMS in alignment with GxP 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. • Drive periodic reviews and revisions of quality documents to ensure ongoing compliance and operational relevance. • Own the CSV/CSA program for GxP computerized systems, ensuring systems are validated commensurate with risk and intended use. • Review and approve validation plans, protocols, and summary reports for new system implementations, upgrades, patches, and configuration changes. • Partner with IT/GxP Systems and system owners to define validation requirements for new tools and integrations before go-live.

🎯 Requirements

• Bachelor’s degree in STEM or related field or equivalent work experience. • Minimum 10+ years of experience in quality assurance, compliance • Hands-on experience administering an electronic QMS platform including LMS. • Strong working knowledge of QMS principles, GxP requirements (especially GCP/GLP and GMP), and relevant regulatory standards (FDA, EMA, ISO 9001, VICH). • Strong track record leading or supporting FDA/regulatory inspections. • Track record of success and a broad understanding of current QA practices as they apply to animal health and quality assurance. • 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.

🏖️ 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