Director, Clinical Quality & Development Operations

Vertex Inc.•Boston, MA

2d•$184,000 - $276,000•Hybrid

About The Position

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.

Requirements

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 analytical skills in a fast-paced environment.
Expert knowledge in system/technical tools and processes
Results oriented
Significant experience with line management of employee
Excellent leadership and interpersonal skills with an ability to effectively work and problem solve within a multidisciplinary team
Experience in collaborating and working with global and cross-functional teams
Excellent oral and written communication skills to influence, inform, or guide others and to communicate complex concepts
Demonstrated adaptability, flexibility, independence and resourcefulness to thrive in a mid-sized company environment
Proven successful track record in maintaining knowledge and compliance of regulatory requirements
Bachelor of Science degree in a life sciences discipline
Typically requires 10 years of experience, or the equivalent combination of education and experience, in the biopharmaceutical industry
3 years of supervisor/management experience

Nice To Haves

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Responsibilities

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
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.
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.
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