Senior Manager, Medical Device Quality & Compliance

AbbVie; North Chicago (IL); Sur place; USD 125 000 - 237 000; Plein temps

Résumé du poste

AbbVie Inc. is seeking an experienced Quality Assurance leader to support the medical device and combination product business.

The role drives the design, implementation, and sustainment of required device regulations across global operations, partnering with R&D, Manufacturing Science, Supply Chain, Regulatory Affairs, and other functions. Responsibilities include developing QA policies, overseeing training, and coordinating cross-functional activities to ensure compliance with corporate and

Qualifications

• Bachelor's degree and 8+ years in quality assurance or quality system oversight.
• Knowledge of device, biologics and pharma regulations; ISO, US CFR, EU rules.
• Experience leading cross-functional teams and solving complex problems.
• Strong communication and regulatory interface abilities.

Responsabilités

• Develop and implement quality assurance policies and procedures for medical devices and combination products.
• Oversee quality system elements, training, continuous improvement, and cross-functional support across sites.
• Ensure compliance with corporate, division, and site policies for device quality systems.
• Support new product introductions and design changes for medical devices and combination products.
• Manage training for revised quality policies and procedures for medical devices.
• Represent AbbVie on external industry groups as appropriate.
• Coordinate consolidation of quality oversight with Regulatory Affairs, R&D, and Operations Quality Management.
• Collaborate with leadership to achieve goals and strategic initiatives.

Connaissances

Quality Assurance

Leadership

Regulatory knowledge

Cross-functional teams

Problem solving

Formation

Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical or scientific area

Description du poste

AbbVie Inc. is seeking an experienced Quality Assurance leader to support the medical device and combination product business.

The role drives the design, implementation, and sustainment of required device regulations across global operations, partnering with R&D, Manufacturing Science, Supply Chain, Regulatory Affairs, and other functions. Responsibilities include developing QA policies, overseeing training, and coordinating cross-functional activities to ensure compliance with corporate and