Director, R&D Quality, GCP (Cell Gene Therapy)

Job DescriptionDirector, R&D Quality, GCP - Cell Gene Therapy (CGT)The Director of R&D Quality, GCP - Cell Gene Therapy (CGT) reports directly to the Head of RDQA and is a trusted advisor and partner to clinical and quality stakeholders and business partners. This role supports the program and study level quality leads in key quality-related clinical activities and deliverables for all CGT programs across the Vertex clinical portfolio. The Director, R&D Quality, GCP consults as necessary with quality and study teams on advanced GCP quality assurance oversight and management activities to ensure the highest level of compliance in Vertex CGT clinical trials, in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, clinical protocols, and Vertex policies, procedures, and quality standards as set forth in the Quality Management System.The Director, R&D Quality, GCP applies their knowledge and understanding of cell and gene therapy industry best practices as a consultative partner and serves to enable the business to meet regulatory submission and program timelines while maintaining a state of inspection readiness. This individual has demonstrated experience in leadership and excels at influencing cross-functional program teams and key stakeholders with their deep subject matter expertise to maintain the highest overall standard of compliance. They are able to distill complex risks and issues into meaningful updates to senior leadership while coaching and mentoring others to understand issues from a risk-based prioritization and compliance lens. The Director, R&D Quality, GCP is a strong collaborator with good judgment and business acumen, willing to mentor and coach junior Quality Associates, and will have meaningful input in creating metrics, Quality Tolerance Limits (QTLs), and Key Performance Indicators (KPIs) for Quality Leadership and Program updates.The Director, R&D Quality, GCP works directly with the RDQA and Quality Leadership Team to elevate overall CGT capabilities, compliance understanding, and expertise by supporting the development of a CGT Center of Excellence that promotes education, awareness, and fit-for-purpose tools, templates, libraries, and training materials.Key Responsibilities:The responsibilities of this position may include, but are not limited to, the following:ConsultationCell & Gene consultant, trusted advisor and partner to internal customers, partners, and stakeholders within R&DQA, QA, and Vertex.Collaborates with Global Regulatory Affairs to address Cell & Gene specific questions from regulatory agencies.Liaise with Regulatory Intelligence to identify, understand, and interpret new/revised regulations and guidelines.Supports Program and Study Quality Leads as the resident cell and gene compliance expert.Integration and CollaborationServe as a collaborator and integrator across multiple functions and business stakeholders.Works closely with VCGT Operation Quality and other identified stakeholders.Collaborate with business stakeholders and functions to ensure transparency and advance quality outcomes.Risk Identification and ManagementIdentifies, quantifies, and contributes to mitigation of C&G specific risks.Establish a fit-for-purpose, modality-specific risk profile for all programs.Teach & DevelopElevate overall capabilities, understanding, and expertise within the CGT space.Stays informed and up to date on CGT regulations/guidelines.Liaise with PMSO to identify and train on new/revised regulations/guidelines.Quality Strategy & ComplianceCollaborates with GCP Operational Quality to establish program level quality oversight.Collaborates with GCP Operational Quality and relevant stakeholders to define regulatory inspection readiness strategy.Additional TasksIdentify areas of improvement and participate in continual quality process improvement initiatives.May own CGT standards and author/revise Standard Operating Procedures (SOPs).Education and ExperienceBachelor's degree in a scientific or allied health field (or equivalent degree).5+ years' experience and demonstrated background in GCP Quality oversight of Cell and Gene Therapy modalities/programs.At least 10 years of GCP Operational QA experience in addition to 5 years of management experience.Preference for candidates with GLP and/or GVP experience.Preference for candidates with a Legal, Privacy or Regulatory background.Flex Designation:Hybrid-Eligible Or On-Site EligibleCompany InformationVertex 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.

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