Inspire · 3 hours ago

Director, Compliance

United States

Full-time

Remote

Director/Executive

$125K/yr - $175K/yr

6+ years exp

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Responsibilities

Develop and maintain annual compliance calendar and schedule:

Necessary audit events (internal, vendor and client)

Documentation reviews

Assessments (risk and vendor)

Revisions to standing policies

Certifications (e.g., SOC2)

Oversee audits and manage findings and oversee remediation, if necessary

Create, maintain and audit logs and matrices:

CAPA

Approved Subcontractor List (ASL)

Data Requests

Training records

Build and manage QMS including HIPAA, CCPA, GDPR, 21 CFR Part 11, GxP, SOC, ISO, etc

Communicates with sponsor(s) audit/quality organizations and teams

Support overall organizational development of SOPs and regulatory standards

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Compliance ManagementQuality Management System (QMS)Clinical Trial ExperienceClinical Research Organization (CRO)Pharmaceutical Quality StandardsRisk AssessmentAudit Management

Required

6 + years of clinical trial and compliance experience, or equivalent

Proven experience leading and understanding of Clinical Research Organization (CRO) and Pharmaceutical quality organizations’ expectations and requirements

Practical application of quality controls in clinical research (Phase I-IV studies) and how to build/implement them effectively

Strong business understanding is essential to align product strategies with overall business objectives

Proven ability as an effective leader capable of inspiring and motivating teams, set a clear vision, foster collaboration, and empower their team members to achieve their full potential

Excellent communication skills to convey complex ideas, assess risk and build constructive remediation plans for issues and preventative action plans for risks

Adaptability and flexibility to changing priorities, and demonstrated ability to work creatively and effectively in a fast-paced environment

Attention to detail and ability to work simultaneously on multiple projects. An entrepreneurial spirit and drive