Director, Clinical Quality & Development Operations

General

Summary:

The Director, Clinical Quality & Development Operations (CQDO) Operational Excellence provides strategic leadership and operational oversight of Global Clinical Operations (GCO) Ancillary Supply Management, Phase 1 Center of Excellence Alliance, Safety Distribution as well as Training & Development programs. The Director drives the execution of departmental strategy, ensuring robust processes, inspection readiness, and compliance across all areas. In addition, the Director serves as a key liaison, that overall supports GCO, advancing business processes and systems to drive effectiveness, standardization, and productivity.

• Defines and executes the overarching vision and strategy for Operational Excellence ensuring alignment with GCO and enterprise objectives.
• Provide leadership and coordination across all domains to ensure operational excellence and ensure timely delivery of all goals.
• Maintains inspection readiness and compliance within all domains and adherence to regulatory standards.
• Builds and maintains strong and productive relationships with key stakeholders within GCO, the Quality Organization, and LMS Organization influencing senior stakeholders and contributing to enterprise-level decision-making.
• Oversees strategic vendor relationships, including selection, performance monitoring, and risk mitigation for ancillary supplies, safety submissions, and training services.
• Provides strategic oversight for GCO-wide training programs, competency development, and continuous learning initiatives to build a high-performing workforce.
• Establishes and tracks key performance indicators for compliance, operational efficiency, and strategies initiatives; communicates progress to senior leaderships.
• Advanced leadership and execution of business strategy
• Comprehensive understanding of own discipline concepts and principles in multiple disciplines and a broad knowledge of others. Oversees multiple projects within domain in support of CQDO deliverables and is a SME for their domain.
• 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
• Drive the development of innovative solutions that address evolving business needs in line with standards
• 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.
• Deep understanding of concepts and principles in own discipline. Basic knowledge of other disciplines. Responsible for managing technical tasks or assigned as a SME for more than one area.
• Maintain understanding of the stakeholder landscape and identify areas for alignment across stakeholders.
• Communicate clear and convincing opinions, ideas, and positions, tailored to the audience, in a poised, confident, and convincing manner.
• Develop solutions that fully address business needs and align standards.
• Guides others either internally or externally to adopt a different point of view.
• Guided by policies and departmental plan, impacts the team’s ability to achieve objectives.
• Express views with conviction that gains support from stakeholders, even when they may have a different opinion or when the subject matter is unfamiliar.
• Provides mentorship, leadership and guidance to junior level staff or FSP employees.
• As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff

• Advanced understanding of GCP, CFR and ICH guidelines and Health Authority regulations

• Advanced ability to leverage knowledge of organizational goals and interdependencies with other functional areas to drive success

• Significant experience managing clinical quality activities and in-depth knowledge of clinical operations

• 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 Operations, and Global Medicines Development & Medical Affairs program strategy and goals

• Leads major projects in support of GCO infrastructure and makes department-wide decisions.

• Demonstrated attention to detail, accuracy, excellent review and…