[Hiring] Director, Clinical Quality & Development Operations @Vertex Inc.

Role Description

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.
• Provides 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 leadership.
• 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.
• Leverages knowledge of the potential future stakeholder landscape to support the pipeline and identify influential stakeholders, internal and external, to Vertex.
• Drives the development of innovative solutions that address evolving business needs in line with standards.
• Identifies and resolves technical and operational problems, understanding broader impact on the department.
• Provides strategic input to solve complex problems while exercising judgment using multiple sources of information.
• Maintains understanding of the stakeholder landscape and identifies areas for alignment across stakeholders.
• Communicates clear and convincing opinions, ideas, and positions, tailored to the audience, in a poised, confident, and convincing manner.
• Develops solutions that fully address business needs and align standards.
• Guides others either internally or externally to adopt a different point of view.
• Expresses 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.

Qualifications

• 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.
• Leads cross-functional projects of high complexity with cross-functional team members and represents 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 employees.
• 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.

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.

Benefits

• Medical, dental, and vision benefits.
• Generous paid time off (including a week-long company shutdown in the Summer and the Winter).
• Educational assistance programs including student loan repayment.
• A generous commuting subsidy.
• Matching charitable donations.
• 401(k) and more.

Company Description

Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States.