CMC Quality Manager, Analytical

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November 20

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Loyal

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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.

51 - 200 employees

⚕️ Healthcare Insurance

🤖 Artificial Intelligence

☁️ SaaS

📋 Description

• Provide quality oversight for analytical method development, qualification, validation, and transfer in support of veterinary drug substance and drug product programs. • Review and approve analytical study protocols, validation reports, method transfer packages, and specifications. • Ensure that analytical testing, release, and stability studies are executed under GMP/GLP conditions and in compliance with FDA and ICH/VICH guidelines. • Partner with Analytical Development, QC, and Manufacturing to ensure accuracy, reliability, and consistency of analytical data. • Support establishment of phase-appropriate specifications, stability-indicating methods, and control strategies aligned with regulatory expectations. • Ensure analytical activities comply with FDA-CVM, ICH, and VICH quality and data integrity requirements. • Provide quality input for analytical sections of CMC documentation (e.g., INAD, NADA, VMF, and stability summaries). • Participate in the preparation and review of regulatory submissions and responses to health authority questions. • Support internal and external audits of analytical laboratories, contract testing organizations (CTOs), and contract manufacturing organizations (CMOs). • Lead or assist in investigations (e.g., OOS/OOT results, deviations), ensuring root cause analysis, CAPA development, and timely closure. • Author, review, and approve SOPs, technical documents, and quality records associated with analytical testing, method lifecycle, and data management. • Maintain inspection readiness and ensure compliance of analytical documentation with company policies and regulatory standards. • Support implementation and continuous improvement of the Quality Management System (QMS) related to CMC and analytical operations. Contribute to risk assessments for analytical methods, materials, and laboratory processes.

🎯 Requirements

• Bachelor’s degree in a scientific discipline (Pharmaceutical Sciences, Chemistry, Veterinary Science, or related field). • Minimum 5-7 years of relevant pharmaceutical industry experience, with at least 6 years in GxP QA roles. • Broad understanding of drug substance and drug product development and manufacturing, analytical methods and testing, and quality incident management. Experience with solid dosage forms and/or veterinary drug products preferred. • Demonstrated success working with external manufacturing partners (CDMOs). • Strong knowledge of FDA CVM regulations, cGMP, and VICH guidelines applicable to veterinary products. • Exceptional written and verbal communication skills. • Ability to manage multiple projects and priorities in a fast-paced, remote work environment. • Detailed eye for logistics and problem solving. • Willing to work and comfortable in a fast-paced startup environment with a dynamic team. • Familiarity with Google Workspace applications (e.g., Sheets, Slides, etc.) and electronic Quality Management Systems. • Experience with international regulatory environments (EU, Canada, etc.) a plus.

🏖️ 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