Senior Director, Quality Control – Analytical Development

Vaga não está no LinkedIn

🕒 Julho 9

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $230.000 - $280.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Diretor

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Loyal

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

A Loyal é uma plataforma digital de saúde líder de ponta a ponta, projetada para unificar os pontos de contato de atendimento para pacientes e provedores. Com foco em melhorar a experiência de saúde por meio da tecnologia, a plataforma integra aprendizado de máquina, processamento de linguagem natural e soluções de gestão de dados líderes do setor. A Loyal oferece ferramentas para gerenciamento de dados de provedores e localizações, engajamento digital, otimização de busca de atendimento, autoagendamento de pacientes, IA conversacional, campanhas de CRM, lembretes de consultas e gestão de reputação. Ela ajuda sistemas de saúde a transformarem suas operações, aumentarem o engajamento dos pacientes e melhorarem os resultados de saúde, garantindo acesso contínuo a informações e processos de atendimento.

Descrição

• Set and execute the global analytical development and quality control strategy aligned with Loyal’s corporate and CMC objectives. • Own the end-to-end analytical and QC lifecycle from early development through commercialization, including commercial QC readiness, product release, stability programs, and post-approval lifecycle management. • Serve as the accountable executive for GMP analytical and QC operations, ensuring inspection-ready systems and sustained regulatory compliance. • Act as a senior CMC leader on cross-functional program teams, influencing development strategy, timelines, and investment decisions. • Lead the development, validation, transfer, and lifecycle management of analytical methods and control strategies, with immediate focus on small-molecule oral solid dosage products, while supporting additional modalities as the pipeline evolves. • Lead cross-functional identification and lifecycle management of CQAs, specifications, and control strategies. • Establish and oversee commercial QC operations, including governance of external GMP testing laboratories and service providers. • Provide executive oversight of deviations, investigations, OOS/OOT events, and CAPAs related to analytical and QC activities. • Serve as a senior analytical subject-matter expert in interactions with FDA Center for Veterinary Medicine (CVM) and other global animal health regulatory agencies, including regulatory submissions, responses, and inspections. • Select, manage, and govern external analytical laboratories, CDMOs (as applicable), and other partners to ensure technical performance, compliance, and cost effectiveness. • Build, scale, and lead a high-performing QC and analytical development organization, including hiring, mentoring, and developing senior technical leaders. • Establish operating models that balance internal capabilities with strategic outsourcing to support a growing and commercial portfolio. • Manage resource planning, aligning analytical and QC investments with pipeline priorities and long-term business objectives.

🎯 Requisitos

• Ph.D., M.S., or B.S. in Analytical Chemistry, Chemistry, or a related scientific discipline. • 18+ years of progressive experience in analytical development and quality control for pharmaceutical products, with deep expertise in small-molecule oral solid dosage forms. • Demonstrated experience spanning early development, clinical programs, commercial launch, and post-approval lifecycle management. • Proven success building and leading analytical and/or QC organizations, including hiring, mentoring, and developing senior technical leaders. • Extensive experience with analytical method development, phase-appropriate validation, method transfer, and GMP QC operations. • Strong knowledge of animal health regulatory requirements, including FDA CVM and relevant global guidelines (e.g., VICH; ICH as applicable), with direct experience supporting regulatory submissions and inspections. • Track record of effective oversight of external GMP testing laboratories and analytical service providers, including governance, performance management, and quality issue resolution. • Strategic mindset with the ability to translate scientific and regulatory complexity into clear, actionable business recommendations. • Comfortable operating in a fast-paced, growth-stage environment, balancing hands-on technical leadership with executive-level decision-making. • Excellent communication and influencing skills, with the ability to engage credibly with executive leadership, regulators, and external partners.

🏖️ Benefícios

• 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