Senior Director, R&D Global Clinical Quality

Job Description

General Summary:

The Senior Director, R&D Global Clinical Quality is a key leadership role in the R&D Quality (RDQ) organization that will provide strategic leadership and direction to the advancement of the framework, capabilities, and sustainability of the Quality Assurance (QA) function, driving the execution and delivery of key quality deliverables across the Vertex clinical research/trial portfolio through the use of leading practices that keep pace with the evolving organization and industry. This role will also provide strategic direction and oversee advancement of the risk management and inspection readiness framework with responsibility for strategic management and hosting and support of regulatory inspections, as well as, oversight of effective and sustained quality risk mitigation and continual improvement strategies.

The Senior Director, R&D GCP Operations ensure effective and proactive quality risk management across the Vertex Clinical Portfolio with overall responsibility for lifecycle review of risks to quality through ensuring appropriate oversight, mitigation strategies and plans enabling clinical quality outcomes and establishing a steady state of real time inspection readiness. This individual will partner closely with the Therapeutic Area lead and program leadership in the design and execution of program quality strategy, will provide transparent insights into program risk and issues, and will deliver proactive and sustainable clinical quality and compliance for assigned programs. This individual will integrate end-to-end quality principles and review preparedness at key milestones in alignment with organizational and project milestones. They will foster strong collaboration and partnership with quality and business stakeholders and ensure alignment with Senior Quality Leadership, R&D Quality leadership and teams (e.g. audit, vendor management) in development of integrated strategies for development program oversight and assurance. They will have demonstrated success in engaging clinical/medical teams and cross-functional stakeholders for collaboration in applying modernized quality practices encouraged by global regulators (e.g. clinical Quality by Design) for outcomes and operational excellence, balancing design of models with practicality of application for effectiveness of outcomes. They will also be responsible for the management, development and oversight of a team of high functioning Program and Study Quality Leads accountable to the delivery and execution of key quality oversight activities and deliverables at the program and study levels that align with the corporate strategy and that of their business partners. This will require exhibiting leadership abilities including influencing without authority, strong collaboration working toward "we wins", executive presentation experience and contribution to a Leadership Team.

Key Duties and Responsibilities:

* Sits as an ambassador and active contributor to RDQA leadership and strategy as a member of the RDQA Leadership Team.
* Provides strategic direction and oversight to development, execution, and continual improvement of Program and study level quality risk management/mitigation strategies for all Vertex Programs.
* Design program-specific quality strategy and partner with business stakeholders across Global Clinical Operations, Medical Affairs, Regulatory, etc. for alignment of quality strategies, goals and approaches in support of quality outcomes and real time inspection readiness.
* Provides leadership to implementation of risk-based approaches to quality for clinical development program(s) - e.g. Quality by Design principles, risk-based quality management (RBQM) and ensures effectiveness of mechanisms for ongoing quality risk monitoring, mitigation and management.
* Provides strategic oversight and ensures development, implementation and maintenance of the program quality plan summarizing the result of evidence of quality activities.
* Leads and/or provides strategic direction/oversight to program-focused quality working groups to define integrated quality plans/activities.
* Engages and provides consultation to senior and executive leadership, therapeutic area partners and key stakeholders and business partners in advancing proactive and leading quality approaches for clinical development program design and execution.
* Serves as an escalation point of contact or Quality representatives and leaders to cross-functional clinical development teams, therapeutic area Leadership and quality governance bodies as applicable.
* Manages For-cause, critical and/or complex quality issues for the program area including representation at Event Action Committees (EACs), Quality Review Boards (QRBs)and Senior Quality Leadership team (SQLT) risk and metrics reviews.
* Responsible for the seamless integration and smooth transition of newly acquired or onboarded business partners and affiliates ensuring their programs are appropriately assimilated into the Vertex Portfolio and part of the Vertex governance infrastructure.
* Strategic leadership of proactive inspection readiness strategies and review at key project milestones in support of organizational deliverables and decision-making models.
* Ensures a steady state of inspection readiness at all times for all studies and programs.
* Directs and leads the design, execution and continual improvement of proactive compliance oversight strategies and programs for independent oversight of operational execution, effectiveness of quality systems and standards, and adherence to internal and external regulatory requirements and expectations.
* Oversees the overall performance and effectiveness of the Internal Audit program in assuring regulatory compliance, quality risk management/mitigation, and adequacy and adherence to controls for quality and compliance with global GxP regulatory requirements, guidance, etc.
* Partners with GMP and GMP to establishe the product lifecycle management oversight program ensuring GxP compliance/quality oversight across a product/program portfolio.
* Manages and mentors Quality professionals for a diverse portfolio of products, technologies, and
geographic span (small molecule, diagnostics, continuous manufacturing, cells, vectors, combination devices, global/regional/country).
* Oversees the GxP risk assessment profile across the Quality Management System with the objective of ensuring transparency for gaining insights regarding state of compliance and adherence with quality standards/requirements across operational and Quality areas providing strategic input to improvement initiatives for advancing operational excellence in quality.
* Partners with other Quality area heads to ensure alignment of strategic and operational goals with priorities of the business and QA for delivery of results necessary.
* Represents Vertex to various health authorities; gain acceptance and build trust externally as well as internally across various functions.
* Anticipates the impact of the changing domestic and international regulatory environment, exiting legislation and guidelines on the development of plans, implementation strategies and post-marketing maintenance.
* Provides leadership and management of monitoring of the external environment for leading practices, emerging trends and projection of future industry and QA capabilities requirements.
* Partners with key stakeholders for alignment in strategic and operational planning and delivery of business priorities and goals.
* Represents QA organization and serves as consultant, trusted advisor and partner to internal and external customers, partners, and stakeholders.
* Apply risk management principles to decision making and operational priorities.
* As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.
* Strategic leadership of proactive inspection readiness strategies and review at key project milestones in support of organizational deliverables and decision-making models.

Knowledge and Skills:

* Broad and deep global health regulatory agency knowledge and experience interpreting and applying GCP/PV requirements.

* Knowledge and demonstrated experience in application of risk-based quality principles in a clinical development setting.
* Demonstrated strategic planning and execution skills required.
* Proven ability to design/evolve and /or implement quality strategies and operational planning and oversight in a fit-for-purpose manner enabling effectiveness, flexibility and adaptability in a dynamic and evolving business model.
* Current knowledge of industry trends and best practices for effective and tailored quality strategies in a research and development setting.
* Developing individuals and teams; proven leadership capabilities within multi-level organization
* Creative, innovative leadership experience complemented with strong change management experience, adaptability, resourcefulness.

* Excellent communication skills and a proven track record of Influencing/building/promoting a culture of Quality and Excellence.

* Strong problem solving and critical thinking skills required to make sound decisions

Education and Experience:

* M.S (or equivalent degree) and 10 +years of relevant work experience, B.S. in a scientific or allied health field (or equivalent degree) and 15+ years of relevant work experience, or relevant comparable background
* Typically requires 15+ years of relevant experience in a pharmaceutical, medical device or biologics company, and 10 years of supervisory/management experience, or the equivalent combination of education and experience.

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Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. 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.

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