AbbVie · 1 day ago
Manager, Design Quality - Lifecycle Management
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 Manager of Design Quality - Lifecycle Management will be responsible for ensuring compliance and quality during product transfers from development to manufacturing, while leading cross-functional teams and managing design change projects.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
Responsibilities
Primary driver for the quality and compliance aspects of product transfer and on-market change management
Serves as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of AbbVie
Lead/support process validation activities (IQ/OQ/PQ/PPQ), including TMV
Mentor/lead product team members through the design transfer process providing guidance to assure optimal approach
Lead/support lifecycle design change projects following Design Control and Change Control principles
Own change plans to manage on-market design changes, collaborate with cross-functional team for impact assessments, define and execute action plans, and monitor to ensure timely closure
Ensure design control documentation (Traceability/Linkages) & design change control requirements are met
Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure
Assist 3rd party suppliers during change management process, including change management strategies
Identify gaps in existing processes as well as the need for new processes. Lead cross-functional teams for solution development and implementation
Support the preparation of regulatory inspections and internal audits and represent QA in inspections and audits as SME
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
Makes recommendations for key decisions on product quality, compliance and regulatory conformance issues
Establishes and maintains relationships and open communication with suppliers, contract 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
Initiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions
Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements. Write/review policies/processes/procedures and related documents
Conduct, lead, or participate in investigations and review boards for Change Plans, CAPAs, NCRs, Observations, etc
Qualification
Required
Bachelor's 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
Working knowledge of ISO 13485, ISO 14971, 21 CFR 4, 21 CFR 820, EU Regulation 93/42/EEC (MDD) & 2017/745 (MDR)
Able to travel up to 10% of the time
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Long-term incentive programs
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
2026-01-11
2026-01-09
2026-01-09
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