AbbVie · 8 hours ago
Senior Analyst, PQA
North Chicago, IL
Full-time
Onsite
Senior Level
6+ years expAbbVie is a company dedicated to discovering and delivering innovative medicines and solutions that address serious health issues. The Senior Analyst, Post-Market Surveillance role focuses on Post-Market Risk and involves maintaining and evaluating the Quality Management System while ensuring compliance with regulatory requirements.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
Responsibilities
Assess trends escalated by Signal Detection, as assigned
Conduct investigations for CAPAs, NCRs, Observations, etc
Coordinate and schedule post-market reporting activities (e.g., CERs, PMCFP/PMCFR, PMSP/PMSR/PSURs, etc.)
Author or update Post-Market Reporting documents (e.g., PMCFP/PMCFR, PMSP/PMSR/PSURs, PRER, etc.)
Work with internal business partners to ensure timely collection and assessment of relevant data (e.g., complaint trends, literature reviews, medical assessments) to drive evidence-based conclusions regarding product performance and safety
Escalate discrepancies and confirmed or potential Quality issues to management
Develop Quality Plans and manage projects, as assigned
Support interactions with regulatory authorities (e.g., Notified Body audits)
Write and revise process-related procedures, forms, and other documents, as needed
Qualification
Required
Bachelor's degree preferably in Engineering or Science
Six years of experience within the Pharmaceutical operations, preferably Biologic manufacturing process
Knowledge of GMP regulations and standards affecting pharmaceutical products
Comprehensive knowledge and application of business and quality concepts
Strong analytical skills and attention to detail
Change plan, Exception Reports, SAP and LRMS experience is highly preferred
Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences
Strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization
Preferred
Experience with ComplianceWire, Global TrackWise, and/or OneVault
Experience working with EU MDR 2017/745, 21 CFR 820
Working knowledge of current MDCG relevant to Post-Market Reporting
Experience with post-market reporting and/or data analysis
Scientific/Medical background
ASQ Certification (e.g., CQA, CQE) or equivalent
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