Job Title: Process Excellence Manager (Regulatory Affairs)
Duration: 10+ Months (Potential Extension)
Location: North Chicago, IL 60064 (Hybrid)
Summary:
The 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.
Key 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 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.
Qualifications:
- 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 plus
- Required Experience: 5+ 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
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Spectraforce Technologies
Aug 25, 2026