Senior Manager, Medical Device & Combination Product Quality Systems

North Chicago, IL - USA

Monthly Salary: Not Disclosed

Posted on: 11-10-2025

Vacancies: 1 Vacancy

Job Summary

Purpose:

The Senior 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 serves as Deputy Person Responsible for Regulatory Compliance for assigned Device Legal Manufacturer 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.

Responsibilities:

Serves as the Deputy Person Responsible for Regulatory Compliance for assigned Device Legal Manufacturer under EU MDR 2017/745 supporting quality management supervision under the direction of the Management Representative.
Hosts External Audits primarily in the US region 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 investigation and corrective action planning in response to external and internal audit observations in collaboration with departmental process owners and subject matter experts.
Maintains expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
Performs regulatory compliance assessments to support the decision-making in critical business decisions including Market Actions.
Analyzes & interprets quality system performance metrics presenting to Top Management as part of Management Reviews.
Program manages initiatives intended to improve and globalize the AbbVie quality management system.

Qualifications :

Qualifications

Bachelors degree preferably in engineering physical science (e.g. Chemistry) life science(e.g. Microbiology or Biology) or pharmacy and a minimum of 8 years of industry experience in a GXP regulated environment with a minimum 3 years in Quality Assurance Operations Management. A strong technical background is required because the scope of responsibilities is broad and requires the ability to communicate understand and direct individuals in highly specialized technical fields.
ISO 13485 Lead Auditor certification by a professional body is required. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE) Six Sigma Black Belt Certification or Project Management Professional (PMP) Certification.
The role operates with a high degree of autonomy & accountability making independent quality & 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.
Quality Assurance Quality Control Regulatory Manufacturing Laboratory or Validation background in a GXP regulated environment is required.
Thorough documented understanding/knowledge of GXP regulations. Regulatory inspection experience preferably with direct agency inspector interaction.
Must have understanding and ability to anticipate and manage the sensitive nature of proprietary information.
Strong project management skills are essential.
Excellent oral and written communication skills required with the capability of clearly presenting and justifying quality requirements.
Key leadership competencies include cultural awareness relationship building ability to influence at all levels of the organization teamwork building sound judgement and the ability to make difficult decisions often at short notice.

Key Stakeholders

External Manufacturing Business Relationships Operations Third Party
Manufacturers Business Alliance Commercial Global Supply Chain Domestic and International AbbVie Plants and Affiliates Regulatory Affairs Research and Development.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
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.
This job is eligible to participate in our long-term incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.

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.

US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Employment Type :

Full-time

Purpose:The Senior 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 serves as Deputy Person Responsible for Regulatory Compliance for assigned Device Legal...

Purpose:

Responsibilities:

Serves as the Deputy Person Responsible for Regulatory Compliance for assigned Device Legal Manufacturer under EU MDR 2017/745 supporting quality management supervision under the direction of the Management Representative.
Hosts External Audits primarily in the US region 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 investigation and corrective action planning in response to external and internal audit observations in collaboration with departmental process owners and subject matter experts.
Maintains expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
Performs regulatory compliance assessments to support the decision-making in critical business decisions including Market Actions.
Analyzes & interprets quality system performance metrics presenting to Top Management as part of Management Reviews.
Program manages initiatives intended to improve and globalize the AbbVie quality management system.

Qualifications :

Qualifications

Bachelors degree preferably in engineering physical science (e.g. Chemistry) life science(e.g. Microbiology or Biology) or pharmacy and a minimum of 8 years of industry experience in a GXP regulated environment with a minimum 3 years in Quality Assurance Operations Management. A strong technical background is required because the scope of responsibilities is broad and requires the ability to communicate understand and direct individuals in highly specialized technical fields.
ISO 13485 Lead Auditor certification by a professional body is required. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE) Six Sigma Black Belt Certification or Project Management Professional (PMP) Certification.
The role operates with a high degree of autonomy & accountability making independent quality & 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.
Quality Assurance Quality Control Regulatory Manufacturing Laboratory or Validation background in a GXP regulated environment is required.
Thorough documented understanding/knowledge of GXP regulations. Regulatory inspection experience preferably with direct agency inspector interaction.
Must have understanding and ability to anticipate and manage the sensitive nature of proprietary information.
Strong project management skills are essential.
Excellent oral and written communication skills required with the capability of clearly presenting and justifying quality requirements.
Key leadership competencies include cultural awareness relationship building ability to influence at all levels of the organization teamwork building sound judgement and the ability to make difficult decisions often at short notice.

Key Stakeholders

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
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.
This job is eligible to participate in our long-term incentive programs

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.

US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Employment Type :

Full-time

Key Skills

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data integrity
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Project Management
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System Administration
Management System
Procedures
hardware

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About Company

AbbVie

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more

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