New · posted Nov 11
AbbVie · Pharmaceuticals
Senior Quality Risk Management Engineer
- North Chicago, IL
- On-site
- Full-time
- Senior & Principal
The role
The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant.
Supports the Quality Engineering group by auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other quality assurance tasks assigned by the MQA Section Manager and/or the Plant QA Manager.
What you need
What you'll do
- Serve as the site liaison between the Quality Risk Management Center of Excellence (QRM COE) and local stakeholders to support deployment of global QRM processes and communication of site feedback.
- Provide QRM SME oversight and guidance for risk management activities, such as FMEAs and other risk assessments specified in local and/or global procedures, by supporting cross-functional teams with methodology, procedural expectations, documentation quality, and risk-based rationale
- Provide QRM training and guidance as required, facilitate assignment of appropriate QRM training curricula to site personnel based on their risk-related responsibilities, and promote QRM best practices.
- Support Management Review activities by compiling and presenting required QRM metrics, site plans for upcoming FMEAs or other relevant risk assessments, significant residual risks, upcoming and past due mitigation actions.
- Monitor the site Quality Risk Management program to support adherence to global QRM procedures, risk outputs, and mitigation action status.
- Participate in global and local QRM documentation changes and change control activities by assessing site impact and providing QRM input as applicable.
- Participate in the Validation Review Board discussions as the QRM SME, providing risk-based input to support validation, commissioning, qualification, and change-related decisions.
- Support the ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
- Own and maintain applicable site-level Quality Risk Management documents and provide QRM expertise for the development, review, and facilitation of risk assessments used to support risk-based decisions, quality event investigations, and other site or product-specific risk evaluations.
- Bachelor's degree, preferably in Biology, Chemistry or Engineering
- 6+ years of overall experience in Manufacturing, Quality or Engineering
- Good verbal and written communication skills.
- Good problem solving and analytical skills
- Good interpersonal relations / communications skills
- Good negotiation skills
- Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- 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. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
Pay and benefits
$85,000 – $162,000 a year
Employer providedPaid time off
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Where you'll work
North Chicago, ILOn-siteOpen in Maps (opens in a new tab)
More jobs in North Chicago, IL
From the posting
About AbbVie
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. 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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Equal opportunity, accessibility and legal noticesAbbVie's statements, word for word
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with the US median for Quality Engineering roles at this level.
This roleEmployer provided
Senior & Principal roles in Illinois11 roles publishing pay
Senior & Principal roles in the US103 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $85,000 | — | $162,000 |
| Illinois (middle half) | $126,500 | $126,500 | $126,500 |
| All US (middle half) | $104,500 | $123,500 | $138,500 |
This role: AbbVie's own published range. Comparisons: the base pay employers published on open Quality Engineering roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Engineering
The general path across 218 open Quality Engineering roles on Regulatory Jobs, with the titles they carry most. Not AbbVie's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs6
- Quality systems and risk6
- Collaboration and leadership5
- GMP and compliance3
- Lab testing and methods2
- Investigations and CAPA2
- Validation and qualification2
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Engineering work in pharmaceuticals, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk managementNamed in the posting
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- ASTMASTM E2500(official source, opens in a new tab)Specification, design and verification of pharmaceutical manufacturing systems and equipment
- ISOISO/IEC 17025(official source, opens in a new tab)Competence of testing and calibration laboratories
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDA21 CFR Part 4(official source, opens in a new tab)Current good manufacturing practice for combination products
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ICHICH Q8(R2)(official source, opens in a new tab)Pharmaceutical development and quality by design
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
Company hiring pulse
AbbVie on Regulatory Jobs
- 74
- Open roles
- 74
- Distinct roles
- 17
- Locations
By discipline
- Clinical60 52%
- Quality29 25%
- Regulatory26 23%
By level
- Director52 45%
- Manager28 24%
- Senior & Principal20 17%
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Senior Quality Risk Management Engineer at AbbVie
Open until filled. $85K–$162K a year, employer provided.