Mgr, Drug Product Development & Manufacturing
Listed on 2026-10-09
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Engineering
Regulatory Compliance Specialist, Quality Engineering -
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
Manager, Drug Product Development and Manufacturing, focused on support and oversight of device combination drug product manufacturing at CMOs.
Responsibilities:facilitate commercial manufacturing, conduct technical reviews, collaborate with cross-functional teams (Supply Chain, Quality, Regulatory), provide engineering expertise on device components, maintain technical documentation, support process validation, manage technical issues with device suppliers, ensure compliance with regulatory and quality standards, and contribute to inspection readiness.
Requirements:Bachelor's in Pharma Sciences, Engineering, or Chemistry; minimum 4 years' experience in development and commercialization of device combination products; knowledge of device quality systems (21 CFR Part 820/4, ISO 13485), risk management (ISO 14971), and GMP device manufacturing; experience with human factors, dose delivery, container systems, extractables/leachables; familiarity with quality systems, SOPs, and regulatory guidelines; proficiency in statistical analysis and technical documentation.
Preferred:experience working with contract manufacturers, in a regulated environment, with multi-cultural teams; strong communication skills; travel up to 25%.
High Value:device combination products, commercial manufacturing, regulatory compliance, technical oversight, process validation, cross-disciplinary collaboration.
Work Setup:remote US-based with approximately 25% travel.
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