Manager, Design Quality Late-Stage Development
Core
Lead quality and compliance for New Product Introduction (NPI) of combination products and medical devices, ensuring on-time delivery and regulatory adherence across global manufacturing and third-party partners.
Role type
Manager, Design Quality Late-Stage Development
Builds
Combination products and medical devices for AbbVie and partners
Domain
Life Sciences / Medical Devices / Regulatory Quality
Required skills
Design control, regulatory compliance (device/drug/biologics), cross-functional leadership, risk management, root cause analysis, CAPA, supplier/contract manufacturer management, audit readiness, technical agreement alignment
Preferred skills
Statistics and data analytics, experience with sterile/unsterile devices, process gap identification
Technologies
None stated
Responsibilities
Lead design control activities and reviews; ensure compliance with local, divisional, and corporate policies; manage quality for product transfers and organization optimization; support regulatory inspections and audits; develop global Product Quality Assurance strategy; negotiate with external quality organizations; maintain relationships with suppliers and contract manufacturers; align quality technical agreements with legal contracts.
Seniority
Manager, hands-on IC with team leadership