BioSpace · 2 hours ago

Associate Director, GCP Compliance

United States

Full-time

Remote

Director/Executive

$149K/yr - $234K/yr

8+ years exp

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Responsibilities

Direct and drive the implementation of compliance management related to quality events and internal audits for clinical trial delivery functions including the identification and development of applicable processes and tools

Establish and lead proactive risk-based compliance assessments for clinical trial delivery functions and ensure completion of robust CAPA/EC-related compliance assessments

Develop and report to leadership on key performance indicators and mitigation strategies for clinical trial delivery

Oversee and manage quality events/deviations including root cause analysis, CAPA development and implementation, effectiveness check tracking, and non-compliance reporting

Facilitate clinical trial delivery internal audits with study teams and functional areas including but not limited to: study team preparation, facilitating audit requests, managing audit responses and CAPA development and implementation. Partner with Quality Assurance to ensure appropriate audit scopes and clinical trial delivery participation.

Lead clinical trial functional areas and study teams on issues related to GCP compliance and liaise with study execution teams on compliance to clinical trial delivery procedures and developing effective mitigation and escalation strategies

Proactively identify process/therapeutic area/project risks and develop/lead assessments to assess compliance

Advise process owners and functional areas on the development and implementation of effective mitigation and escalation strategies for projects to address risks and issues

Develop, lead and oversee compliance assessments to address GCP Quality Plan, CAPAs/ECs and liaise with QA to ensure adherence to the plan

Engage and build relationships with clinical trial delivery functions, R&D QA, and other stakeholders on performance metrics, analytics and reporting for GCP compliance activities

Identify, develop, and track KPIs, metrics and dashboards to track process quality and compliance

Responsible for training, coaching and mentoring supervised employees (direct and indirect reports) to create a culture that attracts, retains and develops innovative thinkers

Act as role model for Takeda’s values

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.

GCP ComplianceCompliance ManagementClinical Trial ManagementCAPA DevelopmentRisk AssessmentQuality AssurancePerformance MetricsHealth Care Business AcumenOperational ExperienceLife Sciences DegreePharmaceutical Industry ExperienceGlobal ExperienceStrategic ThinkingCross-Functional CollaborationMentoring

Required

Bachelor’s Degree or international equivalent required; Life Sciences preferred.

8 or more years' experience in the pharmaceutical industry and/or clinical research organization, including 6 or more years in compliance or clinical study management required.

Global/international experience required, including ability to collaborate with colleagues and staff in other locations.

Experience in leading projects and coordinating collaboration with cross-functional teams.

Strong strategic thinking, planning, execution, and communication skills.

Operational experience in clinical development with significant direct exposure to implementation of novel approaches in clinical development.

Health care business acumen with a comprehensive understanding of the pharmaceutical industry.