About this role
The Senior Manager, Process Excellence within Regulatory Affairs, is responsible for managing key process excellence and issue management activities that support compliant, efficient, and inspection-ready Regulatory Affairs operations. This role oversees the Regulatory Affairs Issue and CAPA Management system (RAIM), triages issue records, escalates issues to Exception Reports when warranted, and partners cross-functionally to drive process improvements. Through collaboration with functional and cross-functional stakeholders, the position also supports inspection readiness and audit/inspection response activities, and management of change plans for legacy company integrations into Regulatory Affairs business processes.
Responsibilities:
Manage the Regulatory Affairs Issue and CAPA Management system (RAIM) to ensure issues are appropriately logged, assessed, tracked, and resolvedTriage RAIM issue records to determine severity, impact, and appropriate next stepsEscalate issue records to Exception Reports when needed based on risk, compliance impact, or process significanceProject manage Exception Reports in partnership with cross-functional stakeholders to identify root causes, drive corrective actions, and improve AbbVie processesCollaborate with Regulatory Affairs leaders, Business Process Owners, Quality, and other functions to ensure issue management activities are timely, well-coordinated, and effectiveMay provide support during internal and external audits and inspections, including coordination of documentation, issue follow-up, and response support as neededManage multiple legacy company integrations for Regulatory Affairs business processes through change plans in OneTrackEnsure process documentation, issue records, and change plans are maintained accurately and in alignment with applicable governance expectationsPartner with stakeholders to support effective communication, implementation, and adoption of process changes.This role will work a hybrid work schedule (3 days in office, 2 days remotely) from our Lake County, IL AbbVie headquarters. Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject). Preferred Education: Relevant advanced degree in science or business is preferred. Certification a plusRequired Experience: 8+ years of regulatory, pharmaceutical or device experience.Experience in Regulatory Affairs, Quality, process excellence, business process management, or related roles is preferredExperience managing issue/CAPA systems, exception reporting, or comparable compliance and investigation workflowsExperience supporting audit and inspection readiness in a regulated environmentStrong organizational, analytical, communication, facilitation, and stakeholder management skillsAbility to manage multiple priorities and work effectively across functions and levelsAbility to influence without direct authority and work in a matrixed environment 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 long-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.
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.
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