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

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 and 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 are 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. These activities include serving as the resident RDQA modality expert providing strategic level quality guidance and oversight of the clinical development programs specifically within our Cell and Gene Therapy (CGT) Disease Areas of the clinical portfolio.

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 as well as maintain 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, is able to view and distill complex risks and issues into meaningful and easily understood updates to senior leadership while coaching and mentoring others to understand issues from a risk-based prioritization and compliance lens as they relate to this specific modality. The Director, R&D Quality, GCP is a demonstrated strong collaborator with good judgement and business acumen, is willing to be a mentor / coach to more junior Quality Associates, partners across Vertex Quality to understand critical touch points across the program and will have meaningful input to 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 to grow and develop the bench to become experts and specialists in this space in support of optimal onboarding, training, learning and development.

Key Responsibilities:

The 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. Develop partnerships across the QA and Vertex organization to drive collective learning around cell and gene therapy best practices and understanding.
• Works closely with VCGT Operation Quality and other identified stakeholders to understand operations and challenges, identify areas of overlap and facilitate information sharing (e.g. develop information sharing model) and ensure seamless transition and management of issues.
• Collaborate with business stakeholders and functions (e.g. RWE Quality) within the quality organization with the objective of ensuring transparency, advancing quality outcomes, and delivering 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 to grow and develop the bench to become experts and specialists within this space. These processes will support optimal onboarding through assuring fit-for-purpose curriculum, training, learning and development.
• 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 impact of change.

Quality Strategy & Compliance

• Collaborates with GCP Operational Quality to establish program level quality oversight and audit strategy for performance oversight. Aligns with GMP Quality to ensure holistic oversight.
• Collaborates with GCP Operational Quality, PMSO (Reg. Intel) and Audits, Inspection Management and relevant stakeholders 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 to ensure the protection of subjects' safety, rights, and well-being as well as the integrity and credibility of data generated.

• Liaise with key stakeholders and business partners to promote high level of quality and consistency across and within programs in CGT.
• 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 to drive proactive and predictive quality improvements. Review and analyzes key Performance Indicator data and trends. Provides input on Quality Tolerance Limits (QTLs) in collaboration with Clinical Operations business partners
• Ensure and support quality and study teams in maintaining a state of inspection readiness for assigned Programs.
• To drive process improvement, provide specialized knowledge and consultative guidance on GxP business initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial conduct and/or regulated drug development activities.
• 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, which includes Performance Management (goals, monitoring, reviews), Employee Learning and Development (Identification of training needs and support of aspirational goals, Talent Acquisition/ Recruiting/Interviewing/ selection, Onboarding/ Transition/Succession Planning, and Oversight of day-to-day execution
• 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 collaborates 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 for assigned programs, ensures audits are conducted in accordance with the plan, reviews audit reports, evaluates responses and CAPA plans in accordance with company standards and policies; assess impact of audit finding and other identified compliance risks to subject safety, data integrity and business operations and escalates significant compliance risks

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 the equivalent combination of education and experience
• Preference to candidates with GLP and / or GVP experience in addition to the required GCP background
• Preference for candidates with a Legal, Privacy or Regulatory background, in addition to Quality, including prior experience working for a Health Authority

Flex Designation:

Flex Eligibility Status:

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