Director, Clinical Quality & Development Operations

Vertex Inc.; United States; Híbrido; USD 184.000 - 276.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote-Eligible

Descripción de la vacante

Vertex Inc. is seeking a Director of Clinical Quality & Development Operations (CQDO) Operational Excellence to lead Global Clinical Operations across Ancillary Supply Management, Phase 1 Center of Excellence, Safety Distribution, and Training & Development programs.

The role drives strategy, ensures inspection readiness, and builds productive stakeholder relationships to advance standards, processes, and productivity within a mid-sized biopharma environment.

Formación

• Advanced understanding of GCP, CFR and ICH guidelines.
• Ability to align domain strategy with enterprise goals.
• Extensive clinical quality activity management experience.
• Lead cross-functional projects of high complexity.

Responsabilidades

• Define and execute the vision and strategy for Operational Excellence across GCO.
• Provide leadership and coordination to ensure timely delivery of goals.
• Maintain inspection readiness and regulatory compliance across domains.
• Foster relationships with key stakeholders and influence enterprise decisions.
• Oversee vendor relationships for ancillary supplies, safety submissions, and training services.
• Oversee GCO-wide training programs and competency development.
• Establish and track KPIs for compliance and efficiency.
• Mentor junior staff and manage assigned personnel.

Conocimientos

GCP knowledge

CFR/ICH familiarity

Clinical quality management

Cross-functional leadership

Strategic planning

Stakeholder management

Problem solving

Regulatory compliance

Mentorship

Communication skills

Educación

BSc in life sciences

10+ years biopharma ops

3+ years people management

Herramientas

Clinical systems

Descripción del empleo

Job Description

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.

Key Duties and 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
• 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

Knowledge and Skills

• 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

Education and Experience

• 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

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.

Pay Range

$184,000 - $276,000

Disclosure Statement

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to 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 so much more.

Flex Designation

Remote-Eligible

Flex Eligibility Status

In this Remote-Eligible role, you can choose to be designated as:
1. Remote : work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select
2. Hybrid : work remotely up to two days per week; or select
3. On-Site : work five days per week on-site with ad hoc flexibility.

#LI-Remote

Company Information

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. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [e-mail]