Labcorp · 17 hours ago

QA Associate Director, Regulatory Intelligence

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$120K/yr - $140K/yr

10+ years exp

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Responsibilities

Supports and drives activities to ensure appropriate regulatory intelligence and compliance information is maintained and made available across the company.

Provides regulatory intelligence to the organization, identifies potential compliance issues in a timely manner, and ensures they are reported to the appropriate levels of management to achieve satisfactory resolution for the business.

Develop targeted summary documents, internal guidance, position papers, training materials and communications to ensure leadership and staff are informed on regulatory compliance information, risks and trends, and how existing procedures might need to be amended to remain in compliance.

Provides appropriate regulatory compliance information, advice, support and training to project teams and clients, proactively communicating important changes and their potential impact.

Contributes towards the promotion of LabCorp regulatory compliance expertise, both internally and externally, by collaborating with colleagues and project teams members in support of Labcorp's mission, contributing to conference presentations and journal publications, and active participation in appropriate professional bodies.

Research and evaluate compliance risks and possible solutions, provide appropriate regulatory compliance information, advice, support and training to project teams and clients, proactively communicating important changes and their potential impact.

Promote regulatory compliance expertise, both externally and internally, by collaborating with colleagues and project teams in support of Labcorp presentations and journal publications, and actively participating in appropriate professional bodies and regulatory forums.

Support client-facing staff by proactively providing advice on complex regulatory compliance issues.

Interact directly with clients on compliance issues that are escalated from project teams.

Support Regulatory Intelligence and Compliance in proposal discussions and bid defenses.

Support regulatory authority inspections at Labcorp facilities.

Qualification

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Regulatory IntelligenceRegulatory AffairsGxP ComplianceProcess ImprovementProject ManagementLife Sciences DegreeChange ManagementMentoring