Combination Product Device Quality Manager

North Chicago, IL - USA

Monthly Salary: Not Disclosed

Posted on: 18 hours ago

Vacancies: 1 Vacancy

Job Summary

Responsible for quality of assigned combination products and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local divisional and corporate policies and external agency regulations worldwide. Products include injection devices infusion pumps enteral and sub-cutaneous tubing and other drug administration system accessories. Products may be produced by AbbVie plants or by third-party manufacturers in licensing relationships or co-marketing relationships. Collaborates to develop the appropriate regulatory strategies for product brands in concert with Regulatory Affairs.

Ensures delivery of quality elements needed to facilitate on-market support for the combination products and medical devices.
Supports Global Product Quality Assurance strategy and implements agreed strategy to support the products at AbbVie plants.
Makes key decisions on product quality compliance and regulatory conformance issues for medical devices and combination products and ensures risk-based elevations to AbbVie leadership.
Leads the collection verification and improvement of Quality metrics for management review in partnership with senior leadership to develop a clear picture of overall compliance state and linking this to local/global project implementation.
Leads a team of SMEs and provides an oversight for project activities and the team members (within and outside of AbbVie) to achieve on-time quality deliverables high customer value and profitable results. Primary driver for the quality and compliance aspects of product transfers on-market support and organization optimization.
Participates in the development of global Product Quality Assurance strategy to support device and combination products produced at AbbVie plants as well as contract manufacturing and supplier facilities. Implements agreed strategy.
Communicates and negotiates with external companies quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide AbbVie with the agreed service. Prioritizes programs initiatives and problem solving with consideration for impact to timelines resources and conflicting priorities.
Interfaces with AbbVies audit team to develop audit plans due diligence plans and inspection readiness plans review audit observations and responses and maintain corrective action timetable.
Provides support for quality audits initial site approvals and due diligence activities. Leads and manages pre-approval inspection readiness as related to contract manufacturers to ensure regulatory approvals are obtained with no delays to market entries.
Participates and leads product quality investigations to identify root cause and implement corrective actions. Coordinates activities to support follow-up on complaint trend investigations for non-medical and medical (adverse events). Supports the management of exception documents and Corrective and Preventive Actions.
Collaborates with internal and external partners in providing feedback on product quality for management reviews with assigned contract manufacturers that identify and address quality operational and organizational issues.

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 postingbased 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 orless 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 commissionincentive 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 paidand 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

Ensures delivery of quality elements needed to facilitate on-market support for the combination products and medical devices.
Supports Global Product Quality Assurance strategy and implements agreed strategy to support the products at AbbVie plants.
Makes key decisions on product quality compliance and regulatory conformance issues for medical devices and combination products and ensures risk-based elevations to AbbVie leadership.
Leads the collection verification and improvement of Quality metrics for management review in partnership with senior leadership to develop a clear picture of overall compliance state and linking this to local/global project implementation.
Leads a team of SMEs and provides an oversight for project activities and the team members (within and outside of AbbVie) to achieve on-time quality deliverables high customer value and profitable results. Primary driver for the quality and compliance aspects of product transfers on-market support and organization optimization.
Participates in the development of global Product Quality Assurance strategy to support device and combination products produced at AbbVie plants as well as contract manufacturing and supplier facilities. Implements agreed strategy.
Communicates and negotiates with external companies quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide AbbVie with the agreed service. Prioritizes programs initiatives and problem solving with consideration for impact to timelines resources and conflicting priorities.
Interfaces with AbbVies audit team to develop audit plans due diligence plans and inspection readiness plans review audit observations and responses and maintain corrective action timetable.
Provides support for quality audits initial site approvals and due diligence activities. Leads and manages pre-approval inspection readiness as related to contract manufacturers to ensure regulatory approvals are obtained with no delays to market entries.
Participates and leads product quality investigations to identify root cause and implement corrective actions. Coordinates activities to support follow-up on complaint trend investigations for non-medical and medical (adverse events). Supports the management of exception documents and Corrective and Preventive Actions.
Collaborates with internal and external partners in providing feedback on product quality for management reviews with assigned contract manufacturers that identify and address quality operational and organizational issues.

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 postingbased 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 orless 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

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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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