Manager, Medical Device and Combination Product Quality Systems

Company Description

AbbVie'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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Quality Manager is responsible for leading the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. The role provides compliance subject matter expertise to internal business partners, demonstrates AbbVie quality management system compliance to external regulators and leads continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.

Responsibilities:

• Program manages initiatives intended to improve and globalize the AbbVie quality management system.
• Serves as Process Owner of assigned QMS processes, monitoring process performance while identifying and advancing process improvement initiatives. 
• Maintains expertise in both current and emerging device regulations and standards impacting AbbVie products, performing regulatory compliance assessments to support key business decisions. 
• Analyzes & interprets quality system performance metrics, presenting to Top Management as part of Management Reviews.
• Supports External Audits in key Front and Back Room roles, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits under MDSAP.
• Conducts Internal Audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
• Leads root cause investigations and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts. 

Qualifications