AbbVie · 16 hours ago
Manager, Design Quality - Late Stage Development
North Chicago, IL
Full-time
Onsite
Senior Level
$106K/yr - $202K/yr
7+ years expAbbVie is dedicated to discovering and delivering innovative medicines and solutions for serious health issues. The role involves ensuring the quality of assigned products, including pharmaceuticals and medical devices, while maintaining compliance with regulations and overseeing project activities for on-time delivery.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
Responsibilities
Maintains the primary quality lead with management 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 and organization optimization
Participates in the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, device and combination products produced at AbbVie plants as well as third party manufacturing (TPM) facilities. Implements agreed strategy
Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers
Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium and high risk events to AbbVie management. Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled. Helps facilitate resolution in cases where they are not
Establishes and maintains relationships and open communication with Third Party Manufacturers, AbbVie plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns
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 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. Provides support for quality audits, initial site approvals and due diligence activities. Leads and manages pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries
Contributes to Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer’s that provide products directly to distribution centers, or to AbbVie domestic and International plants for further packaging and/or testing. Coordinates activities to support follow-up on compliant trend investigations for non-medical and medical (adverse events). Supports the management of exception documents and Corrective and Preventive Actions
Completes management reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues. Obtains and reviews summaries of the Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from the Third Party Manufacturer to ensure accuracy, completeness, timeliness, and trends are identified and addressed in an appropriate manner
Qualification
Required
Bachelor's Degree in relevant Engineering, Life Science or other technical discipline or equivalent job experience required
7+ years of total combined experience. At least 5 years in Operations Quality Assurance, 3 years in Operations, Research and Development or Consulting
Knowledge and a comprehensive understanding of combination products, medical devices and manufacturing processes
Understanding of regulations and standards affecting combination products and medical devices required
Must have leadership skills and have been seen to take a position on Quality issues and standards and must be capable of clearly and logically justifying such positions
Sound technical understanding of product development (e.g. approaches for definition of requirements and specification setting for verification and validation) and/or practical experience in design control
Well-versed in risk management methodologies and their application
Able to take the initiative to identify and implement new approaches to resolve problems, able to challenge scientific arguments - strong analytical approach to identify problem areas and effective solutions
Work independently and in a global team environment, and with all levels of personnel within the organization
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
Preferred
Experience with root cause investigations, CAPA, statistics and data analytics is a plus
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Company
AbbVie
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
10001+ employees
H1B Sponsorship
AbbVie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Robert Michael
Chairman of the Board and Chief Executive Officer
Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
Recent News
2026-01-09
2026-01-08
Morningstar.com
2026-01-08
Company data provided by crunchbase