Quality Risk Management SME – GMP & Validation Lead

AbbVie; North Chicago (IL); On-site; USD 95,000 - 150,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Job summary

AbbVie in North Chicago, IL seeks a Senior Quality Engineer to lead Manufacturing Quality Assurance activities, investigate deviations, manage risk assessments, and ensure cGMP compliance at the plant. You will oversee calibration, CAPA, and QA programs while supporting cross-functional teams and regulatory readiness.

Ideal candidates bring 6+ years in manufacturing quality or engineering, strong communication, problem-solving and negotiation skills, and knowledge of API/Drug manufacturing

Qualifications

• Bachelor's degree in Biology, Chemistry or Engineering.
• 6+ years of experience in Manufacturing, Quality or Engineering.
• Strong communication and analytical skills.
• Knowledge of quality / compliance management as well as regulations affecting API, Bulk Drug or Finished goods manufacturing.

Responsibilities

• 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.

Skills

Communication skills

Problem solving

Interpersonal skills

Negotiation

Quality compliance

Education

Bachelor's degree in Biology, Chemistry or Engineering

Job description

AbbVie in North Chicago, IL seeks a Senior Quality Engineer to lead Manufacturing Quality Assurance activities, investigate deviations, manage risk assessments, and ensure cGMP compliance at the plant. You will oversee calibration, CAPA, and QA programs while supporting cross-functional teams and regulatory readiness.

Ideal candidates bring 6+ years in manufacturing quality or engineering, strong communication, problem-solving and negotiation skills, and knowledge of API/Drug manufacturing