AbbVie
Quality Systems Manager
North Chicago, IL, United States · Senior
Sponsorship not specifiedDetected 12 hours ago
Supply ChainGMPFDA RegulatoryPharmacovigilanceMedical DevicesLeadershipCommunication
Stay score
odds of building a lasting career here
38Risky
Cap-exempt (no lottery)0
Sponsors this role85
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
Thin sponsorship signal and lottery-bound. A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
Lottery odds assume a STEM candidate.
Personalize to your clock →Employer immigration record
from this employer's Department of Labor filings
Green-card follow-through: 59%
Of 22 labor certifications old enough to have been used, 9 expired without the employer filing the next step. Median time from filing to decision: 480 days.97% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.
DOL often reclassifies their job titles
The Department of Labor assigned a different occupation than this employer requested on 44% of its 55 wage determinations — against a 18% norm. The occupation sets the prevailing wage floor.Reclassification is routine and can reflect genuinely hybrid roles; it is not by itself evidence of underpayment.
Files H-1B transfers
7 transfer filings in the last year, covering 7 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
Community outcomes
No reports yet — be the first to help the next applicant.
About the role
- Specific areas of responsibility may include supplier qualification and approval, supplier risk management,, supplier change management,, and Approved Supplier List (ASL) governance.
- This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.
Responsibilities
- Ensure proper integration and support of quality regulations: drug, biologics, cosmetic, device and/or combination products.
- Lead project teams in planning, preparation, review and approval of quality documentation.
- Coordinate quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates.
- Interact with internal and external partners for development of best practices in our quality systems and procedures.
- Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
Requirements
- 8+ years' experience in quality assurance, quality oversight or relevant experience.
- Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.
- Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.
- Experience working in both team setting and independently.
- May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
Nice to have
- Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
- Excellent interpersonal skills a plus.
Benefits
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- Support new product introduction for pharmaceutical products, medical devices, or combination products.
- Support design changes to existing medical devices and combination products.
- Oversee the implementation and management of training and education programs for various aspects of quality assurance.
- 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.
Company info
- We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
Equal opportunity
- Employer/Veterans/Disabled.
- US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
- US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
- https://www.abbvie.com/join-us/reasonable-accommodations.html
This listing is sourced directly from AbbVie's careers page and normalized into a canonical job model.