Position Title: Senior Manager, Quality Control - Drug-Device Combination ProductsQuality Control is responsible for pre-commercial development and commercial activities including the operational aspects of commercial drug device combination product, drug substance, device and packaging components. This work includes release testing, stability programs, methods transfers, and validations at external laboratories and Contract Development and Manufacturing Organizations (CDMOs).
This position serves as a Quality Control subject matter expert for combination products, ensuring appropriate control strategies are in place for drug substance, drug product, and device components, and partners closely with Quality Assurance, Regulatory Affairs, Technical Operations, and external partners to maintain inspection readiness.
Preferred Location: Remote - USEssential Duties and 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.
*Additional duties and responsibilities as assigned.
Qualifications (Education & Experience)Required 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
- 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.
Preferred Qualifications- Experience working within ISO 13485-aligned quality systems.
- Experience supporting EU MDR or global device regulatory submissions.
- Background supporting combination products such as prefilled syringes, autoinjectors, or other delivery systems.
- Experience contributing to CMC sections of U.S. or EU regulatory filings involving combination products.
- Familiarity with data integrity requirements and lifecycle management of analytical methods for combination products.
Additional Requirements- Proficiency with MS Office and laboratory and quality systems (LIMS, QMS, EDMS).
- Demonstrated alignment with Esperion's values and culture.
- Ability to work effectively in a fully remote environment.
- Moderate domestic and international travel required (up to 20% annually).
