Manager, Design Quality Late-Stage Development

AbbVie

AbbVie seeks a Manager of Design Quality for late-stage development of combination products and medical devices. The role involves leading quality strategies, ensuring regulatory compliance, and managing cross-functional teams to deliver compliant products on schedule.

Responsibilities

Serve as primary quality lead for new product introduction projects and cross-functional teams
Lead design control activities including design reviews and requirement verification
Manage design change control and assess impacts on product safety and efficacy
Oversee supplier and contract manufacturer quality agreements and compliance
Support regulatory inspections, audits, and pre-approval inspection readiness

Requirements

Bachelor's degree in engineering, life science, or equivalent technical discipline
7+ years combined experience; at least 5 years in operations quality assurance
3+ years in operations, research and development, or consulting
Comprehensive knowledge of combination products, medical devices, and manufacturing
Understanding of device and drug regulations and design control processes
Leadership skills with demonstrated quality standards advocacy
Risk management and design control experience preferred

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Vacancy posted 8 days ago

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