Manager, Medical Device and Combination Product Quality Systems

AbbVie • North Chicago, IL

1d

About The Position

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 . 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.

Requirements

• Bachelor’s Degree in relevant Life Science or other technical discipline or equivalent job experience required.
• 7+ years of total combined experience.
• At least 5 years in Quality Assurance Operations Management; 3 years in Operations, Research and Development or Consulting.
• 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 solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, members and individuals.

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.

Benefits

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager