Job Description
As a Quality Management Systems Manager, you will play a key role in sustaining, improving, and globalizing AbbVie's quality management system to support medical devices and combination products.
This position serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745. You will provide compliance subject matter expertise to internal business partners, demonstrate AbbVie quality management system compliance to external regulators, and lead continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.
* Serve as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.
* Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
* Conduct internal audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
* Lead root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
* Maintain expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
* Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions, including Market Actions.
* Analyze and interpret quality system performance metrics, presenting to Top Management as part of Management Reviews.
* Program-manage initiatives intended to improve and globalize the AbbVie quality management system.
Qualifications
We are looking for a highly skilled professional with a Bachelor's degree preferably in engineering, physical science, life science, or pharmacy, and a minimum of 7 years of industry experience in a GXP regulated environment. Preferred certifications include ISO 13485 Lead Auditor and additional accreditations such as American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE), Six Sigma Black Belt Certification, or Project Management Professional (PMP) Certification.
Work Arrangement
This is a hybrid role with 3 days on site and 2 days remote.