Lead mentor and develop a team of quality professionals and subject matter experts (SMEs) responsible for design controls and quality management during design transfer of new products and ongoing lifecycle projects for on-market products.
Oversee execution and fulfillment of quality requirements for lifecycle management of on-market products, including change control for on-market devices, execution of assurance of supply projects and geographic expansions.
Facilitate effective Change Control activities, including design change impact assessments and approval of relevant changes.
Develop design control strategies along with the cross-functional team to verify, validate and implement on-market design changes.
Develop, implement, and continually improve global quality assurance strategies in partnership with Regulatory Affairs, Marketing, Operations, Product Development, and other cross-functional teams.
Make key strategic decisions regarding product quality, compliance, and regulatory matters, escalating significant risks to AbbVie leadership as needed.
Collect, validate, and analyze quality metrics, present compliance status and actionable insights for local and global initiatives during management reviews.
Partner with cross-functional team and third-party manufacturers to maintain consistent quality standards and minimize compliance risks.
Support and drive continuous improvement by identifying gaps or improvement opportunities within Design History Files, risk management, processes, and policies and tracking actions to closure.
Foster a culture of proactive quality, cross-functional collaboration, and ongoing process improvement.
Bachelor's Degree in relevant Life Science or other technical required. Graduate degree desired. Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues.
Strong quality assurance / control, manufacturing, laboratory, technical support, regulatory, and / or validation background is required.
Experience working the requirements for third party external manufacturing.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), m
Benefits
Vision insurancePaid time off
Additional Information
The Associate Director of Design Quality - Design Lifecycle Management oversees the Design Lifecycle Management team responsible for combination products and medical devices. This leadership role manages the seamless design transfer of new product designs into manufacturing, directs design change management for products already on the market, and executes assurance of supply projects. The team also drives initiatives supporting geographic expansion and other lifecycle management activities. The role ensures all assigned products-including on-body delivery systems, pre-filled syringes, auto-injectors, infusion pumps, tubing, pump accessories, and aesthetics medical devices such as breast implants, fillers and body contouring devices-meet business objectives, and comply with local, divisional, corporate, and global regulatory standards.
Abbvie · North Chicago, IL