Senior Manager, Quality Control - Drug-Device Combination Products
$166,500–$193,000 year
RemoteUnited States
Job Summary
Lead Quality Control for pre-commercial development and commercial activities of drug-device combination products, including release testing, stability programs, and method transfers at external laboratories and CDMOs. Review and approve development, release, and stability data for routine manufacturing, investigations, and deviations involving drug substance, drug product, and device components. Design, implement, and maintain Quality Control processes for specifications, analytical methods, protocols, and reports, ensuring alignment with established schedules, quality requirements, and budget commitments. Serve as the primary technical liaison with CDMOs and external testing laboratories while supporting regulatory submissions and acting as QC lead during FDA, EU, and partner audits. Partner with Quality Assurance on investigations, change controls, and risk assessments, and track compliance metrics and quality performance indicators.
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, 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
- Ability to work effectively in a fully remote environment
- Moderate domestic and international travel required (up to 20% annually)
Desired Qualifications
- Experience working within ISO 13485-aligned quality systems is a plus
- Experience supporting EU MDR or global device regulatory submissions is a plus
- Background supporting combination products such as prefilled syringes, autoinjectors, or other delivery systems is a plus
- Experience contributing to CMC sections of U.S. or EU regulatory filings involving combination products is a plus
- Familiarity with data integrity requirements and lifecycle management of analytical methods for combination products is a plus
- Proficiency with MS Office and laboratory and quality systems (LIMS, QMS, EDMS)
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