Manager, Medical Device And Combination Product Quality Systems

Overview
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 .
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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.
This role serves as
the Person Responsible for Regulatory Compliance
for the EU Authorized Representative under EU MDR 2017/745, providing compliance subject matter expertise to internal business partners, demonstrating AbbVie quality management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.
Ideally, this person will be based near one of our sites that manufacture medical devices in Ireland, either in Sligo or Westport, otherwise in one of our other Ireland sites.
Responsibilities
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
Bachelor's degree, preferably in engineering, physical science (e.g., Chemistry), life science (e.g., Microbiology or Biology), or pharmacy and a minimum of 7 years of industry experience in a GXP regulated environment.
ISO 13485 Lead Auditor certification by a professional body is preferred.
Additional accreditation by a professional body is desirable; examples include ASQ CMQ-OE, Six Sigma Black Belt, or Project Management Professional (PMP) Certification.
Operates with a high degree of autonomy and accountability, making independent quality and compliance decisions timely and demonstrating the ability to manage multiple commitments while delivering on-time.
The role also demonstrates an enterprise mindset, being able to influence without direct authority and apply past learnings to novel situations.
This is a hybrid role with 3 days on site, 2 days remote.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
Equal Opportunity Employer/Veterans/Disabled.
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