Director of Clinical Quality & Development Ops

Regulatory Jobs

Boston (MA)

Remote

USD 184,000 - 276,000

Full time

6 days ago

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Job summary

Vertex is seeking a Director of Clinical Quality & Development Operations to lead Operational Excellence across Global Clinical Operations. You will oversee ancillary supply management, safety submissions, and training programs, driving standardization and inspection readiness.

This leadership role influences senior stakeholders and shapes enterprise-wide processes. The ideal candidate brings extensive experience in clinical quality, regulatory compliance, and cross-functional leadership within

Qualifications

Advanced understanding of GCP, CFR and ICH guidelines and Health Authority regulations.
Significant experience in clinical quality activities and operations.
Leads cross-functional projects of high complexity in a regulated environment.
Experience managing vendor relationships and compliance programs.

Responsibilities

Define and execute the vision and strategy for Operational Excellence within GCO.
Provide leadership across domains to ensure timely delivery of goals.
Maintain inspection readiness and regulatory compliance across domains.
Build relationships with stakeholders in GCO, Quality, and LMS.
Oversee vendor selection, performance, and risk for ancillary supplies and training services.
Oversee GCO-wide training programs and competency development.
Establish and track KPIs for compliance and efficiency; report to senior leadership.