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
Vacancy posted 8 days ago
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