Company Description
- 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 us at . on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .
Job Description
Purpose:
The Manager, Medical Device External Quality is part of AbbVies External and Product Quality Assurance group and reports to the Senior Manager, Medical Device External Quality. The role will be based out of Lake County, IL site. This role primarily oversees external product quality assurance (EPQA) for commercial medical devices which are manufactured by third parties. In this capacity, the Manager, Medical Device External Quality, champions best practices related to sustaining product quality, equipment qualification, and manufacturing process validations.
As such, the Manager, Medical Device External Quality works closely with AbbVies Contract Manufacturing Organizations (CMOs), relevant third-party suppliers (e.g., custom components), and internal stakeholders to ensure compliance with defined specifications and regulatory requirements. The position also supports Quality Management System activities related to the CMOs, including but not limited to CAPAs/NCRs, Change Control, Complaints, Product Release, Supplier Quality Agreements, etc. Additionally, the Manager, Medical Device External Quality, may support New Product Introduction activities, with particular emphasis on transfer-to-manufacturing. The Manager, Medical Device External Quality provides strong technical leadership in the TPQ Quality function amongst peers, ensuring that functional activities are compliant and aligned with overall company goals and strategies.
Responsibilities:
- Manages CMOs and/or third-party suppliers to assure timely and compliant release ofcommercial products and/or components in accordance with defined specifications and processes.
- Oversee CMOs and/or third-party suppliers to ensure that non-conformances, CAPAs, Reworks, and deviations are accurately documented, reviewed, and approved as well as resolving compliance issues related to commercial product and/or custom components
- Supports New Product Introduction (NPI) activities
- Develops and maintains supplier Quality Technical Agreement. Review and approve changes to supplier processes which impact device and/or component manufacture.
- Review and approve technical protocols, reports, and specifications, as appropriate.
- Supports Quality Systems group during Regulatory inspections (i.e., serve as product SME)
- Participates in the development of global Product Quality Assurance strategy to support medical devices and/or combination products produced at third party manufacturing (TPM) facilities.
- Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers if required.
- Interfaces with Global Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable. Support Supplier Audit function during CMO site audits.
- Leads management reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues. Champions development and maintenance of KPIs and trend analysis at supplier site, as applicable
Qualifications
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.
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 orlocal law:
- The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
- This job is eligible to participate in our short-term incentiveprograms.
- This job is eligible to participate in our long-term incentiveprograms
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.
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. It is AbbVies 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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