Vertex Pharmaceuticals
Director, R&D Quality, GCP (Cell Gene Therapy)
Vertex Pharmaceuticals, Boston, Massachusetts, us, 02298
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 compliance in Vertex CGT clinical trials according to 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, distilling 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 judgement and business acumen, willing to mentor 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.
Key ResponsibilitiesThe responsibilities of this position may include, but are not limited to, the following:Consultation
Cell & Gene consultant, trusted advisor and partner to internal customers, partners, and stakeholders within R&DQA, QA, and Vertex (e.g. CGT Clinical Trial Management key stakeholders).Collaborates with Global Regulatory Affairs to address Cell & Gene specific questions from regulatory agencies or provide input during marketing approval submissions.Liaise with Regulatory Intelligence to identify, understand, and interpret new/revised regulations and guidelines for QA team members and business partners.Supports Program and Study Quality Leads and study execution teams as resident cell and gene compliance expert in the execution and delivery of key study deliverables within the Vertex CGT clinical portfolio.
Integration and Collaboration
Serve as a collaborator and integrator across multiple functions and business stakeholders, fostering collaboration, knowledge sharing, and information management.Works closely with VCGT Operation Quality and other identified stakeholders to understand operations and challenges, identify areas of overlap, and facilitate information sharing.Collaborate with business stakeholders and functions (e.g. RWE Quality) within the quality organization to ensure transparency, advance quality outcomes, and deliver on team objectives and priorities.
Risk Identification and Management
Working closely with GCP Operational Quality and CGT Operational Quality, identifies, quantifies and contributes to mitigation of C&G specific risks.Establish a fit-for-purpose, modality-specific risk profile for all programs within the cell and gene space.
Teach & Develop
Elevate overall capabilities, understanding, and expertise within the CGT space by supporting the development of a CGT Center of Excellence that promotes education, awareness, and fit-for-purpose tools, templates, libraries, and training materials.Stays informed and up to date on CGT regulations/guidelines to ensure compliance.Liaise with PMSO (Reg. Intel) to identify and train on new/revised regulations/guidelines and understand the impact of change.
Quality Strategy & Compliance
Collaborates with GCP Operational Quality to establish program level quality oversight and audit strategy for performance oversight.Collaborates with GCP Operational Quality, PMSO (Reg. Intel), and Audits, Inspection Management to define regulatory inspection readiness strategy.
Additional Tasks
Identify areas of improvement, participate in continual quality process improvement initiatives, and foster best practices.May own CGT standards. Author/revise Standard Operating Procedures (SOPs) and associated forms as necessary.
Other Responsibilities
Serves as a key technical resource for the application of GCP principles in areas such as patient engagement and ethics, quality risk management/mitigation, and subject privacy.Liaise with key stakeholders and business partners to promote high levels of quality and consistency across CGT programs.Partner with QA and business leadership for coordination and alignment in ensuring overall quality and compliance of internal operations and applicable vendors.Support the defining and developing of quality metrics to ensure consistent quality standards relating to GCP activities.Ensure and support quality and study teams in maintaining a state of inspection readiness for assigned Programs.Drive process improvement, provide specialized knowledge and consultative guidance on GxP business initiatives.Participate as a key stakeholder in the evaluation and selection of GCP service providers within the CGT portfolio.May provide functional area leadership and management, including performance management and employee learning and development.May serve as GCP Quality Management System representative.Participate in collaborative review of impacted controlled documentation related to Vertex Standards, SOPs, and Work Instructions.Identify areas for continuous improvement, foster best practices, and participate in quality process improvement initiatives.Provides QA review of protocols and participates on Operational Review Boards to identify operational risks and collaborate with Program and Study teams in development of risk mitigation strategies.Supports Program Quality Leads and Audit and Inspection Management teams to develop risk-based audit plans.
Education And Experience
Bachelor’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 or equivalent combination of education and experience.Preference for candidates with GLP and/or GVP experience in addition to the required GCP background.Preference for candidates with a Legal, Privacy or Regulatory background, including prior experience working for a Health Authority.
Flex DesignationHybrid-Eligible Or On-Site EligibleFlex Eligibility StatusIn this Hybrid-Eligible role, you can choose to be designated as:
Hybrid: work remotely up to two days per week; or selectOn-Site: work five days per week on-site with ad hoc flexibility.
Company 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 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.#J-18808-Ljbffr
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, distilling 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 judgement and business acumen, willing to mentor 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.
Key ResponsibilitiesThe responsibilities of this position may include, but are not limited to, the following:Consultation
Cell & Gene consultant, trusted advisor and partner to internal customers, partners, and stakeholders within R&DQA, QA, and Vertex (e.g. CGT Clinical Trial Management key stakeholders).Collaborates with Global Regulatory Affairs to address Cell & Gene specific questions from regulatory agencies or provide input during marketing approval submissions.Liaise with Regulatory Intelligence to identify, understand, and interpret new/revised regulations and guidelines for QA team members and business partners.Supports Program and Study Quality Leads and study execution teams as resident cell and gene compliance expert in the execution and delivery of key study deliverables within the Vertex CGT clinical portfolio.
Integration and Collaboration
Serve as a collaborator and integrator across multiple functions and business stakeholders, fostering collaboration, knowledge sharing, and information management.Works closely with VCGT Operation Quality and other identified stakeholders to understand operations and challenges, identify areas of overlap, and facilitate information sharing.Collaborate with business stakeholders and functions (e.g. RWE Quality) within the quality organization to ensure transparency, advance quality outcomes, and deliver on team objectives and priorities.
Risk Identification and Management
Working closely with GCP Operational Quality and CGT Operational Quality, identifies, quantifies and contributes to mitigation of C&G specific risks.Establish a fit-for-purpose, modality-specific risk profile for all programs within the cell and gene space.
Teach & Develop
Elevate overall capabilities, understanding, and expertise within the CGT space by supporting the development of a CGT Center of Excellence that promotes education, awareness, and fit-for-purpose tools, templates, libraries, and training materials.Stays informed and up to date on CGT regulations/guidelines to ensure compliance.Liaise with PMSO (Reg. Intel) to identify and train on new/revised regulations/guidelines and understand the impact of change.
Quality Strategy & Compliance
Collaborates with GCP Operational Quality to establish program level quality oversight and audit strategy for performance oversight.Collaborates with GCP Operational Quality, PMSO (Reg. Intel), and Audits, Inspection Management to define regulatory inspection readiness strategy.
Additional Tasks
Identify areas of improvement, participate in continual quality process improvement initiatives, and foster best practices.May own CGT standards. Author/revise Standard Operating Procedures (SOPs) and associated forms as necessary.
Other Responsibilities
Serves as a key technical resource for the application of GCP principles in areas such as patient engagement and ethics, quality risk management/mitigation, and subject privacy.Liaise with key stakeholders and business partners to promote high levels of quality and consistency across CGT programs.Partner with QA and business leadership for coordination and alignment in ensuring overall quality and compliance of internal operations and applicable vendors.Support the defining and developing of quality metrics to ensure consistent quality standards relating to GCP activities.Ensure and support quality and study teams in maintaining a state of inspection readiness for assigned Programs.Drive process improvement, provide specialized knowledge and consultative guidance on GxP business initiatives.Participate as a key stakeholder in the evaluation and selection of GCP service providers within the CGT portfolio.May provide functional area leadership and management, including performance management and employee learning and development.May serve as GCP Quality Management System representative.Participate in collaborative review of impacted controlled documentation related to Vertex Standards, SOPs, and Work Instructions.Identify areas for continuous improvement, foster best practices, and participate in quality process improvement initiatives.Provides QA review of protocols and participates on Operational Review Boards to identify operational risks and collaborate with Program and Study teams in development of risk mitigation strategies.Supports Program Quality Leads and Audit and Inspection Management teams to develop risk-based audit plans.
Education And Experience
Bachelor’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 or equivalent combination of education and experience.Preference for candidates with GLP and/or GVP experience in addition to the required GCP background.Preference for candidates with a Legal, Privacy or Regulatory background, including prior experience working for a Health Authority.
Flex DesignationHybrid-Eligible Or On-Site EligibleFlex Eligibility StatusIn this Hybrid-Eligible role, you can choose to be designated as:
Hybrid: work remotely up to two days per week; or selectOn-Site: work five days per week on-site with ad hoc flexibility.
Company 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 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.#J-18808-Ljbffr