Sr Manager, Quality Control – Drug Device Combination Products

About the role

The Senior Manager, Quality Control – Drug-Device Combination Products position at Esperion is responsible for pre-commercial development and commercial activities related to drug-device combination products. This role involves providing technical and scientific leadership, reviewing and approving data, designing and implementing processes, and supporting regulatory submissions and audits.

Responsibilities

• 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.

Qualifications

• 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, and applicable elements of 21 CFR Part 820.
• 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.