Senior Manager, Quality Control – Drug Device Combination Products

🕒 vor 7 Tagen

🚗 Michigan – Remote

🚗 Michigan – Remote

💵 €166.500 - €175.000 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Manager

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Esperion

WebsiteLinkedInAlle Stellen

201 - 500 Mitarbeiter

Gegründet 2008

🏥 Gesundheitswesen

💼 Beratung

🧬 Biotechnologie

Healthcare • Consulting • Biotechnology

Esperion ist ein führendes globales biopharmazeutisches Unternehmen, das sich auf die Entwicklung innovativer Behandlungen für Herz-Kreislauf-Erkrankungen konzentriert. Durch kommerzielle Umsetzung und internationale Partnerschaften strebt es an, einen breiten Zugang zu seinen zugelassenen Therapien zu ermöglichen. Mit dem Engagement, seine präklinische Pipeline voranzutreiben, ist Esperion Vorreiter in der Forschung zur ACLY-Biologie und entwickelt Next-Generation-Inhibitoren, um dringende gesundheitliche Herausforderungen zu bewältigen.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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