Senior Manager, Quality Control – Drug Device Combination Products

🕒 Julho 30

🚗 Michigan – Remoto

🚗 Michigan – Remote

💵 $166.500 - $175.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

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Esperion

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2008

🏥 Saúde

💼 Consultoria

🧬 Biotecnologia

Healthcare • Consulting • Biotechnology

A Esperion é uma empresa biofarmacêutica global líder focada no desenvolvimento de tratamentos inovadores para doenças cardiovasculares. Através da execução comercial e parcerias internacionais, visa proporcionar amplo acesso às suas terapias aprovadas. Com um compromisso em avançar seu pipeline pré-clínico, Esperion está liderando pesquisas em biologia ACLY e desenvolvendo inibidores de próxima geração para enfrentar desafios de saúde urgentes.

Descrição

• Provide in-depth technical and scientific leadership to contract service providers and internal stakeholders related to Quality Control for drug-device combination products • Serve as the primary QC technical and project management liaison with CDMOs and external testing laboratories supporting drug substance, drug product, and device component testing • Review and approve development, release, and stability data for routine manufacturing, investigations, and deviations involving drug substance, drug product, and combination products • Design, implement, and maintain Quality Control processes for specifications, analytical methods, protocols, and reports, both internally and externally • Recommend and justify product specifications and test methods appropriate to phase of development and product risk, including combination product considerations • Ensure testing and release activities are executed in alignment with established schedules, quality requirements, and budget commitments • Provide QC input and support for combination product design-related activities, including verification/validation testing support as applicable • Support regulatory submissions and act as a QC lead during FDA, EU, and partner audits and inspections, including those involving combination product or device-related scope • Partner with Quality Assurance on investigations, change controls, CAPAs, and risk assessments • Support qualification of alternate manufacturing sites, laboratories, service suppliers, and device component suppliers • Review and approve stability protocols and reports prepared by CMOs; ensure compliance with ICH stability guidelines and applicable drug-device combination product requirements • Review, trend, and interpret drug substance, drug product, and combination product data and contribute to Annual Product Reviews • Review and approve analytical methods, method validation/verification protocols, and reports • Lead or co-lead cross-functional Technical Operations projects and CMO oversight activities • Track, trend, and report compliance metrics and quality performance indicators; recommend and implement supplier performance metrics

🎯 Requisitos

• Bachelor’s degree in Chemistry, Biology, Engineering, or a related scientific discipline • 8+ years of progressive Quality Control experience within the medical device or drug-device combination product industry • Direct experience supporting medical devices and/or drug-device combination products in a regulated GxP environment • Strong working knowledge of: 21 CFR Parts 210/211 (cGMPs), 21 CFR Part 4 (Combination Products), ISO 13485 • Experience leading QC method transfers and validations at external CMOs and testing laboratories • Proven experience managing global external CDMOs and contract testing laboratories • Solid understanding of ICH guidelines, including stability testing requirements for pharmaceutical and combination products • Experience supporting regulatory inspections and audits, including preparation and response activities • Strong project management, communication, and stakeholder-influencing skills in a matrixed environment

🏖️ Benefícios

• Competitive salary including a performance-based bonus program and stock-based compensation • Comprehensive benefits package including a 401(k) matching plan and health insurance • Paid time off and holidays