Associate Director, Design Quality - Design Lifecycle Management

Company Description

About Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on Linked In, ()  Facebook, Instagram () , X ()  and You Tube.

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Job Description

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.

Responsibilities:

+ 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 Abb Vie 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.

Qualifications

+ 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.

+ Total combined years of experience. Minimum of 10+ in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support in a pharmaceutical setting. Required regulatory inspection experience with direct interaction with regulatory inspectors. Direct Plant experience in a pharmaceutical setting with a minimum of 5 years preferred.

+ Knowledge and a comprehensive understanding of some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients).

+ Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem…