Senior Quality Risk Manager – QRM SME & GMP Compliance

Purchaseyourfreedom; North Chicago (IL); On-site; USD 85,000 - 162,000; Full time

Job summary

AbbVie in North Chicago, IL is seeking a Senior Quality Engineer to lead Manufacturing Quality Assurance activities, resolve deviations, perform product impact analysis, and drive CAPA within a cGMP framework. You will coordinate QRM processes, support validation, commissioning, and change decisions, and ensure site practices meet regulatory requirements.

The role involves cross-functional collaboration with the QRM COE, exposure to FMEAs, risk assessments, mentoring on QRM, and documentation

Qualifications

• Bachelor's degree in Biology, Chemistry or Engineering.
• 6+ years of experience in Manufacturing, Quality or Engineering.
• Good verbal and written communication skills.
• Good problem solving and analytical skills.
• Good interpersonal relations / communications skills.
• Knowledge of quality / compliance management as well as regulations and standards 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.

Job description

AbbVie in North Chicago, IL is seeking a Senior Quality Engineer to lead Manufacturing Quality Assurance activities, resolve deviations, perform product impact analysis, and drive CAPA within a cGMP framework. You will coordinate QRM processes, support validation, commissioning, and change decisions, and ensure site practices meet regulatory requirements.

The role involves cross-functional collaboration with the QRM COE, exposure to FMEAs, risk assessments, mentoring on QRM, and documentation