Manager, Medical Device and Combination Product Quality Systems

North Chicago, IL - USA

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job 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 :

Bachelors 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.

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.

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

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 :

Bachelors 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.

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.

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

Time Management
Data Analytics
Analytical
Agile
Requirement Gathering
Strategic thinking
Visio
Communication
Problem Solving
Market Research
UML
Cross Functional Teams

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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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