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Manufacturing Operations Manager - Medical Devices

Jobleads-US
North Chicago, IL Full Time
POSTED ON 4/10/2025
AVAILABLE BEFORE 5/9/2025

Company Overview

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At AbbVie, we are dedicated to discovering and delivering innovative medicines and solutions that address serious health issues. Our mission is to make a remarkable impact on people's lives across various therapeutic areas.

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About Us

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We strive to be a leading global biopharmaceutical company with a diverse portfolio of high-quality products and services. Our commitment to excellence drives us to deliver exceptional results and make a positive difference in the lives of our customers and employees.

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Job Description

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This role will oversee the manufacturing operations of medical devices, ensuring that all products meet the highest quality standards. You will lead a team of professionals responsible for managing third-party manufacturers and ensuring compliance with local and international regulations.

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Key Responsibilities

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  • Manage a team of Manufacturing Professionals responsible for Third Party Manufacture (TPM) contracts for Medical Devices or Combination Products.

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  • Assure that high quality products are manufactured in compliance with local and international regulations, and released and delivered according to the established forecasts, schedules, and cost planned.

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  • Lead a team of AbbVie TPM Account Managers to negotiate and manage Manufacturing Service Agreements (MSA), contract Amendments, and updates as needed, while ensuring compliance with the terms of the agreements.

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  • Ensure global logistics are in place to support all phases of the manufacturing agreement in accordance with Purchasing and Supplier Quality expectations.

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  • Lead the development of ECM Device Financial Operating Plan, Updates, LRP, and Standard processes, and assure the financial goals are met.

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  • Monitor and control manufacturing costs to ensure efficient use of resources while maintaining product quality.

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  • Ensure timely communication with TPM in all aspects of the product agreement including product forecasts, manufacturing and delivery schedules.

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  • Identify, evaluate, and maintain strong relationships with third-party manufacturers to ensure quality production and timely delivery.

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  • Monitor manufacturing performance; apply OPEX (Operational Excellence) metrics as appropriate and ensure TPM manufacturing processes and standards align to deliver product in accordance with AbbVie quality & performance expectations.

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  • Assure in coordination with internal AbbVie functional partners that the TPM has the required quality systems and documentation to meet regulatory requirements, follow up inspection responses and commitments.

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  • Coordinate with PQA, the annual quality management review and periodic audits of the TPM.

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  • Coordinate routine management reviews and provide ongoing communication informing internal and TPM stakeholders of performance against expectations, highlighting issues, actions, and ongoing improvements to increase performance at TPMs.

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  • Foster a collaborative partnership with TPMs to ensure mutual understanding and commitment to quality & performance.

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  • Lead a performance improvement culture & programs across TPMs; guide Account Managers to anticipate and act on ideas to increase efficiency and effectiveness.

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  • Establish and manage clear team expectations regarding roles & responsibilities, G&O's while championing and modeling AbbVie's performance and talent management practices.

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  • Develop and manage staff through hiring, managing performance, developing talent and providing clear expectations.

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  • Bachelor's Degree required in a technical field; 15 years' experience including manufacturing of Medical or Electro-Mechanical Devices.

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  • Strong technical and manufacturing assembly management experience.

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  • Progressively increased responsibility and performance as supervisor, department manager and leader in Operations (Manufacturing, Quality, Engineering, etc.).

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  • Proven ability to inclusively manage and develop teams.

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  • Business acumen coupled with functional leadership experience is required to ensure effectiveness and high performance in a complex operation.

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Benefits

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We offer a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.

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This job is eligible to participate in our short-term incentive programs.

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AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.

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It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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