Manager, Medical Device and Combination Product Quality Systems

Role Summary

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

• 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.

Education

• Bachelor’s Degree in relevant Life Science or other technical discipline or equivalent job experience required.