Senior Manager, Quality Control – Drug Device Combination Products

This is a fully remote position, open to applicants in Michigan.

📋 Description

• Deliver comprehensive technical and scientific guidance to contract service providers and internal teams concerning Quality Control for drug-device combination products.

• Act as the main QC technical and project management liaison with CDMOs and external testing laboratories involved in drug substance, drug product, and device component testing.

• Evaluate and authorize development, release, and stability data for routine manufacturing, investigations, and deviations related to drug substance, drug product, and combination products.

• Develop, implement, and uphold Quality Control procedures for specifications, analytical methods, protocols, and reports, both within the organization and externally.

• Suggest and substantiate product specifications and test methods that are suitable for the development phase and product risk, including considerations for combination products.

• Ensure that testing and release operations are conducted in accordance with established timelines, quality standards, and budgetary commitments.

• Offer QC insights and assistance for combination product design-related initiatives, including verification and validation testing support as necessary.

• Aid in regulatory submissions and serve as the QC lead during FDA, EU, and partner audits and inspections, particularly those related to combination products or device scopes.

• Collaborate with Quality Assurance on investigations, change controls, CAPAs, and risk assessments.

• Assist in the qualification of alternative manufacturing sites, laboratories, service providers, and device component suppliers.

• Review and approve stability protocols and reports generated by CMOs; ensure adherence to ICH stability guidelines and relevant drug-device combination product requirements.

• Analyze, trend, and interpret data for drug substance, drug product, and combination products, contributing to Annual Product Reviews.

• Review and validate analytical methods, method validation, and verification protocols and reports.

• Lead or co-lead cross-functional Technical Operations projects and oversee CMO activities.

• Monitor, trend, and report compliance metrics and quality performance indicators; recommend and execute supplier performance metrics.

⛳️ Requirements

• Bachelor’s degree in Chemistry, Biology, Engineering, or a related scientific field.

• Over 8 years of progressive Quality Control experience in the medical device or drug-device combination product sector.

• Direct experience in supporting medical devices and/or drug-device combination products within a regulated GxP environment.

• Strong understanding of: 21 CFR Parts 210/211 (cGMPs), 21 CFR Part 4 (Combination Products), ISO 13485.

• Experience in leading QC method transfers and validations at external CMOs and testing laboratories.

• Proven track record in managing global external CDMOs and contract testing laboratories.

• Solid grasp of ICH guidelines, including stability testing requirements for pharmaceutical and combination products.

• Experience in supporting regulatory inspections and audits, including preparation and response activities.

• Strong project management, communication, and stakeholder-influencing abilities in a matrixed environment.

🏝️ Benefits

• Competitive salary with a performance-based bonus program and stock-based compensation.

• Comprehensive benefits package featuring a 401(k) matching plan and health insurance.

• Paid time off and holidays.