Senior Manager, Regulatory Affairs Process Excellence

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 resolved
• Triage RAIM issue records to determine severity impact and appropriate next steps
• Escalate issue records to Exception Reports when needed based on risk compliance impact or process significance
• Project manage Exception Reports in partnership with cross-functional stakeholders to identify root causes drive corrective actions and improve AbbVie processes
• Collaborate with Regulatory Affairs leaders Business Process Owners Quality and other functions to ensure issue management activities are timely well-coordinated and effective
• May provide support during internal and external audits and inspections including coordination of documentation issue follow-up and response support as needed
• Manage multiple legacy company integrations for Regulatory Affairs business processes through change plans in OneTrack
• Ensure process documentation issue records and change plans are maintained accurately and in alignment with applicable governance expectations
• Partner 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

Qualifications :

• Required Education: Bachelors degree in life sciences (pharmacy biology chemistry pharmacology or related subject). Preferred Education: Relevant advanced degree in science or business is preferred. Certification a plus
• Required Experience: 8 years of regulatory pharmaceutical or device experience.
• Experience in Regulatory Affairs Quality process excellence business process management or related roles is preferred
• Experience managing issue/CAPA systems exception reporting or comparable compliance and investigation workflows
• Experience supporting audit and inspection readiness in a regulated environment
• Strong organizational analytical communication facilitation and stakeholder management skills
• Ability to manage multiple priorities and work effectively across functions and levels
• Ability to influence without direct authority and work in a matrixed environment

Additional Information :

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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time