Lead senior quality leadership for design, integration, and execution of complex remediation programs at Round Lake Drug Delivery.
The estimated base salary for this position is $112,000 - $154,000 annually.
- Lead development, integration, and execution of site remediation strategies arising from regulatory inspections, Warning Letters, OAI classifications, health-authority commitments, audits, quality-system assessments, and significant recurring quality signals.
- Translate commitments and identified gaps into clearly defined workstreams, accountable owners, milestones, dependencies, deliverables, interim controls, effectiveness measures, and objective closure evidence.
- Establish and maintain a risk-based remediation master plan and governance cadence that provides clear visibility to progress, overdue actions, critical-path constraints, resource needs, decision requirements, and emerging risks.
- Provide independent Quality oversight and constructive challenge to ensure remediation plans are technically sound, scientifically justified, regulatorily defensible, feasible, and aligned with commitments made to health authorities and internal governance bodies.
- Drive cross-functional execution across Quality, Manufacturing, Engineering, Maintenance, Facilities, Laboratories, Supply Chain, Regulatory Affairs, IT, Training, and Operational Excellence to remove barriers and maintain alignment.
Remediation LeadBaxter International Inc. · Round Lake, US