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.

Key Duties and Responsibilities:

• 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-founded 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

Knowledge and Skills:

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

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

• Extensive Global Clinical Operations/Clinical Development experience in multiple therapeutic areas

• Exceptional strategic vision and leadership capabilities

• Expert knowledge in system/technical tools and processes

• Demonstrated attention to detail, accuracy, excellent review and analytical skills in a fast-paced environment.

• Results oriented

• Excellent leadership and interpersonal skills with an ability to effectively work and problem solve within a multidisciplinary team

• Excellent verbal and written communication and presentation skills

• Excellent analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making

• Expertise in drug development, operations and resource/budget planning across global geographies

• Knowledge of emerging technologies and trends.

• Ability to drive innovation and excellence.

• Proven strong business acumen

• Excellent project management, critical thinking and problem-solving skills

• Demonstrated adaptability, flexibility, independence and resourcefulness to thrive in a mid-sized company environment

Education and Experience:

• Bachelor of Science degree in a life sciences discipline
• Typically requires 15 years of experience, or the equivalent combination of education and experience, in the biopharmaceutical industry
• 5 years of supervisor/management experience

Pay Range:

Disclosure Statement:

Flex Designation:

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.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 

#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 ApplicationAssistance@vrtx.com