Vertex Pharmaceuticals
Director, R&D Quality, GCP (Cell Gene Therapy)
Vertex Pharmaceuticals, Boston, Massachusetts, us, 02298
Job Description
Director, 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 with Good Clinical Practice (GCP) guidelines, applicable regulations, clinical protocols, and Vertex policies.
The Director applies their knowledge of cell and gene therapy industry best practices 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, excels at influencing cross-functional program teams, and has the ability to distill complex risks and issues into meaningful updates to senior leadership.
The Director works directly with the RDQA and Quality Leadership Team to elevate overall CGT capabilities and compliance understanding by supporting the development of a CGT Center of Excellence.
Key Responsibilities:The responsibilities of this position may include, but are not limited to, the following:
Consultation
Act as a trusted advisor and partner to internal customers within R&DQA, QA, and Vertex.
Collaborate with Global Regulatory Affairs to address specific questions from regulatory agencies.
Liaise with Regulatory Intelligence to interpret new/revised regulations and guidelines.
Support Program and Study Quality Leads as a compliance expert.
Integration and Collaboration
Foster collaboration and knowledge sharing across multiple functions and stakeholders.
Work closely with VCGT Operation Quality to understand operations and challenges.
Ensure transparency and advance quality outcomes with business stakeholders.
Risk Identification and Management
Identify and contribute to mitigation of C&G specific risks.
Establish a modality-specific risk profile for all programs.
Teach & Develop
Support the development of a CGT Center of Excellence.
Stay informed on CGT regulations to ensure compliance.
Train on new/revised regulations and guidelines.
Quality Strategy & Compliance
Establish program level quality oversight and audit strategy.
Define regulatory inspection readiness strategy.
Additional Tasks
Participate in continual quality process improvement initiatives.
May own CGT standards and author/revise SOPs.
Other Responsibilities:
Serve as a key technical resource for GCP principles.
Promote high levels of quality and consistency across programs.
Support the development of quality metrics for GCP activities.
Ensure quality and study teams maintain inspection readiness.
Provide specialized knowledge on GxP business initiatives.
Participate in the evaluation of GCP service providers.
May provide functional area leadership and management.
Participate in collaborative review of controlled documentation.
Identify areas for continuous improvement.
Provide QA review of protocols and participate on Operational Review Boards.
Support Program Quality Leads in developing risk-based audit plans.
Education and Experience
Bachelor's degree in a scientific or allied health field.
5+ years’ experience in GCP Quality oversight of Cell and Gene Therapy.
At least 10 years of GCP Operational QA experience and 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 Eligible
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; or2. On-Site: work five days per week on-site with ad hoc flexibility.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation and is committed to equal employment opportunity and non-discrimination.
#J-18808-Ljbffr
Director, 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 with Good Clinical Practice (GCP) guidelines, applicable regulations, clinical protocols, and Vertex policies.
The Director applies their knowledge of cell and gene therapy industry best practices 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, excels at influencing cross-functional program teams, and has the ability to distill complex risks and issues into meaningful updates to senior leadership.
The Director works directly with the RDQA and Quality Leadership Team to elevate overall CGT capabilities and compliance understanding by supporting the development of a CGT Center of Excellence.
Key Responsibilities:The responsibilities of this position may include, but are not limited to, the following:
Consultation
Act as a trusted advisor and partner to internal customers within R&DQA, QA, and Vertex.
Collaborate with Global Regulatory Affairs to address specific questions from regulatory agencies.
Liaise with Regulatory Intelligence to interpret new/revised regulations and guidelines.
Support Program and Study Quality Leads as a compliance expert.
Integration and Collaboration
Foster collaboration and knowledge sharing across multiple functions and stakeholders.
Work closely with VCGT Operation Quality to understand operations and challenges.
Ensure transparency and advance quality outcomes with business stakeholders.
Risk Identification and Management
Identify and contribute to mitigation of C&G specific risks.
Establish a modality-specific risk profile for all programs.
Teach & Develop
Support the development of a CGT Center of Excellence.
Stay informed on CGT regulations to ensure compliance.
Train on new/revised regulations and guidelines.
Quality Strategy & Compliance
Establish program level quality oversight and audit strategy.
Define regulatory inspection readiness strategy.
Additional Tasks
Participate in continual quality process improvement initiatives.
May own CGT standards and author/revise SOPs.
Other Responsibilities:
Serve as a key technical resource for GCP principles.
Promote high levels of quality and consistency across programs.
Support the development of quality metrics for GCP activities.
Ensure quality and study teams maintain inspection readiness.
Provide specialized knowledge on GxP business initiatives.
Participate in the evaluation of GCP service providers.
May provide functional area leadership and management.
Participate in collaborative review of controlled documentation.
Identify areas for continuous improvement.
Provide QA review of protocols and participate on Operational Review Boards.
Support Program Quality Leads in developing risk-based audit plans.
Education and Experience
Bachelor's degree in a scientific or allied health field.
5+ years’ experience in GCP Quality oversight of Cell and Gene Therapy.
At least 10 years of GCP Operational QA experience and 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 Eligible
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; or2. On-Site: work five days per week on-site with ad hoc flexibility.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation and is committed to equal employment opportunity and non-discrimination.
#J-18808-Ljbffr