Senior Director, Clinical Quality & Development Ops

Job Description General

Summary:

The Senior Director, Clinical Quality & Development Operations (CQDO) Good Clinical Practice (GCP) Compliance provides enterprise‑level leadership and strategic oversight to ensure Global Clinical Operations (GCO) maintains a sustained state of GCP compliance. The role is accountable for embedding a proactive GCP compliance capability, provides strategic oversight and governance for GCO owned Risk Management Plans (RMPs), clinical site holds and closures, Quality Risks, and Serious Breach assessments, ensuring proactive risk identification, regulatory compliance, and effective quality risk mitigation across the clinical development portfolio.

Through leadership of a high‑performing CQDO team, this role ensures quality and compliance are consistently aligned with GCO objectives and broader corporate strategy.

Lead Quality Event Management activities related to the investigation, root cause analysis and development of corrective action/ preventive action plans for GCO assigned events, including unplanned deviations, corrective/ preventive actions and effectiveness checks ensuring timelines for closure are met

Participate in GCP Event Action Committees (EAC’s) as needed

Leads the development and oversight of GCO owned Risk Management Plans (RMPs), site hold and closure activities, Quality Risks, and Serious Breach assessments, driving quality governance, risk-based decision making, and inspection readiness throughout the clinical trial lifecycle.

Ensure consistency in processes throughout all functions in Global Clinical Operations, and develop method for continuous process improvement

Analyze the risks for readiness and manage the implementation of readiness program, and develop lessons learned after each inspection.

Develop strategy with Global Clinical Operations in the development of CAPA plans and investigations in response to audits and inspections.

Ensure inspections findings are remediated and processes are implemented within GCO.

Oversee the development and implementation of quality frameworks, operational standards, and risk mitigation strategies across clinical programs, with a focus on harmonizing global processes and ensuring compliance with regulatory requirements

Advanced leadership and execution of business strategy

Advanced ability to leverage knowledge of the potential future stakeholder landscape and to support the pipeline and identify those who will be the most influential, internal and external, to Vertex Champions well‑foundated perspectives with authority and strategic insight, inspiring stakeholder confidence and securing buy‑in-even when navigating complex, unfamiliar, or contentious subject matter.

Demonstrates exceptional leadership by fostering open dialogue, addressing divergent opinions constructively, and driving consensus to advance organizational objectives.

Leads the conception and implementation of transformative solutions that proactively address dynamic business challenges, ensuring alignment with industry standards and regulatory requirements.

Demonstrates a forward‑thinking approach by fostering innovation, driving cross‑functional collaboration, and embedding quality and compliance into every stage of solution development.

Identifies and resolves technical and operational problems, understands broader impact on the department.

Provides strategic input to solve complex problems while exercising judgment using multiple sources of information.

As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

Expert ability to leverage knowledge of organizational goals and interdependencies with other functional areas to drive success.

Expert understanding of GCP, CFR and ICH guidelines and Health Authority regulations.

Lead cross‑functional projects of high complexity with cross‑functional team members and represent Clinical Quality & Development Operations on other large‑scale projects/initiatives.

Develops strategy for their domain in alignment with Clinical Quality & Development Operations (CQDO), Global Clinical…