AbbVie · 3 hours ago
Quality Systems Associate Director
North Chicago, IL
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expAbbVie is a company dedicated to discovering and delivering innovative medicines and solutions for serious health issues. The Quality Systems Associate Director is responsible for managing the global supplier audit schedule, overseeing audit processes, and ensuring compliance with quality management systems across the organization.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
Responsibilities
BPO, system oversight and management for Onetrack auditing and supplier management module
Define SQM/supplier audit user requirements and drive system change/enhancements to ensure the system aligns with current business process from beginning to end. Collaborate with BTS to manage incident reporting and define appropriate corrective actions. Develop training materials and continuity planning
This includes ensuring accuracy and maintenance of approximately 3800 quality relevant suppliers in the supplier auditing scope
Oversight of annual global external audit schedule (~ 400+ OSA, 200 global QQ, and 600 local QQ; approx. 800 changes a year with supplier removals, additions and updates) supporting approximately 3800 quality relevant suppliers/TPMs across Abbvie
Managing schedule, updates to plans and annual and global planning of external audit schedule. Opening and closing of scheduling including local low QQs
Ensuring audit prep, and audit support for all audits
Team vets and manages all proposed changes and confirms expectations vs process and support of the changes (CP)
Team owns QMR-01-06-004 and supporting work instructions and tools for process and any changes
Responsible to identify and support process and procedure improvement within audit and supplier management scope (help identify and eliminate pain-points through process improvement and procedure enhancements)
Team owns quarterly auditing CoP and key contributor for Supplier CoE
Team is responsible for all CPs, ERs, and Projects executed within audit team
Team is responsible for tracking training coordination needs within external auditing team
SME and support for all audit and inspection requests for agency, notified body and customer audits for Abbvie for auditing
Team is responsible for monthly reporting of all metrics
Includes tracking new suppliers added, removed and discontinued suppliers cleansed from auditQ and process execution (including CPs, ERs and projects)
Qualification
Required
Bachelor's degree in relevant life science, engineering or other technical discipline (or equivalent work experience to ensure understanding of implications of role to organization and industry) required
Total combined years of experience 10+ years in the pharmaceutical, biologics, device, or chemical industry—a minimum of 5 years of experience in QA operations and 4 years of experience in supplier quality management or similar experiential role
Expert knowledge and a comprehensive understanding of supplier quality management requirements and expectations (focusing on Abbvie and industry expectations). Working knowledge and experience to support agency and notified body inspections queries, requests, or potential deficiency concerns
Strong leadership skills are required to manage professional staff and effectively interface with senior leaders within the organization (especially with managing project requests and challenges with highly visible or challenged projects or project timelines). Capacity to perform as a leader, team member, and individual contributor as needed
Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, positive interpersonal skills, and the ability to manage multiple complex tasks simultaneously
Understanding strategy and tactical needs for auditing organization; to analyze data and facts to support process changes and improvements to meet the expanding needs of supplier auditing within Abbvie
The incumbent must be capable of understanding and overcoming differing cultural and language obstacles to provide solutions that satisfy Corporate, Divisional, regional, and local objectives to effectively manage the action plans
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
2026-01-23
2026-01-20
2026-01-20
Company data provided by crunchbase