Director, GxP Training & Learning Strategy (Hybrid)
Ver-Tex, Boston, MA, United States
Director GxP Training Strategy
We are seeking a Director to define and lead the enterprise GxP training strategy. This role sits at the intersection of business strategy, quality governance, and operational enablement. The Director partners with senior leaders to understand business direction, clarify why training solutions are required, and translate regulatory and operational needs into a clear, prioritized roadmap with defined outcomes and accountability. In parallel, as QSO, the Director holds final authority for the system-level design, governance, compliance, and continuous improvement of the GxP Training Quality System within the Global QMS framework. The Director ensures the system remains compliant, effective, scalable, and inspection-ready across Small Molecule, Cell & Gene Therapy, Biologics, and Device operations. The Director also serves as Business System Owner for the LMS and leads a team of Strategic Training Partners aligned to operational and functional business areas. This is a strategic and governance leadership role requiring business acumen, regulatory judgment, and decision authority. Key Responsibilities Define and evolve the enterprise GxP training strategy in alignment with business objectives, growth plans, and regulatory expectations. Partner with Quality, Operations, and functional leadership to understand operating realities, challenge assumptions behind training requests, and translate business and regulatory requirements into a multi-year roadmap with clear initiatives, milestones, and measurable outcomes. Provide leadership in Global Process Ownership and Compliance (GPOC) by driving proactive quality approaches across the GxP process lifecycle, fostering a culture of continuous improvement, and ensuring that training programs are designed to enhance compliance, mitigate risks, and support operational excellence. Steward the GxP Training Quality System end-to-end within the Global QMS Governance framework. This includes establishing system standards and guardrails, interpreting global GxP expectations into defensible system-level decisions, and governing systemic risks, trends, and compliance posture. Use system-level KPIs, inspection insights, and quality performance data to assess Training Quality System health, drive continuous improvement, and escalate risks when impact exceeds defined thresholds. Represent the Training Quality System credibly and consistently during audits, regulatory inspections, and executive governance reviews. Ensure that technology architecture, configuration, and operating practices support both regulatory integrity and business effectiveness. System design must enable scalability across modalities and outsourced networks while maintaining inspection-ready evidence and disciplined governance. Lead and develop a team of Strategic Training Partners, ensuring they operate as credible, business-aligned advisors. Set clear expectations for business understanding, regulatory fluency, and solution quality, and ensure the team maintains the right mix of expertise to support evolving business needs. The Director remains accountable for overall delivery, prioritization, and performance across the portfolio. Required Capabilities The successful candidate will demonstrate the ability to operate at both strategic and system-governance levels. They must be able to define enterprise direction while stewarding a regulated Quality System with decision authority and accountability. Specifically, this role requires the ability to: Shape enterprise training strategy aligned to business priorities, regulatory expectations, and evolving operating models. In partnership with peers and leadership, drive a culture of quality and continual learning across all aspects of quality, the Quality Management System (QMS), and organizational processes. Translate regulatory requirements into defensible system-level design decisions within a formal QMS governance framework. Govern systemic quality risks and performance trends, using KPIs, inspection insights, and data to drive continuous improvement and informed escalation. Establish and enforce clear system guardrails, ensuring Process Owners and business stakeholders operate within defined standards. Balance compliance and operational practicality, applying risk-based judgment across multiple modalities and global environments. Influence senior stakeholders and governance bodies, communicating system health, risks, and decisions with clarity and credibility. Lead and mature business-aligned partner teams, setting high standards for accountability, capability, and delivery. Exercise decision authority in complex, ambiguous environments, maintaining system integrity while enabling business execution. Required Qualifications Bachelor's degree required; advanced degree preferred. 10+ years of experience in GxP training, quality systems, within regulated operational environments (or demonstrated equivalent) within pharma or biotech. This is highly preferred. 5+ years in a leadership role with accountability for strategy, governance, and people leadership. Demonstrated experience operating within a formal Quality System governance framework with deep expertise in fundamental quality disciplines and requirements (e.g., quality risk management, change management, corrective and preventing action, and inspection readiness). Strong working knowledge of FDA, EMA, and ICH GxP expectations. Proven ability to translate business and regulatory requirements into actionable strategies and defensible system-level decisions. Experience using performance data and quality metrics to inform governance and executive decision-making. Demonstrated ability to exercise sound judgment and lead through complexity. Pay Range: $175,200 - $262,800 Flex Designation: Hybrid-Eligible 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
We are seeking a Director to define and lead the enterprise GxP training strategy. This role sits at the intersection of business strategy, quality governance, and operational enablement. The Director partners with senior leaders to understand business direction, clarify why training solutions are required, and translate regulatory and operational needs into a clear, prioritized roadmap with defined outcomes and accountability. In parallel, as QSO, the Director holds final authority for the system-level design, governance, compliance, and continuous improvement of the GxP Training Quality System within the Global QMS framework. The Director ensures the system remains compliant, effective, scalable, and inspection-ready across Small Molecule, Cell & Gene Therapy, Biologics, and Device operations. The Director also serves as Business System Owner for the LMS and leads a team of Strategic Training Partners aligned to operational and functional business areas. This is a strategic and governance leadership role requiring business acumen, regulatory judgment, and decision authority. Key Responsibilities Define and evolve the enterprise GxP training strategy in alignment with business objectives, growth plans, and regulatory expectations. Partner with Quality, Operations, and functional leadership to understand operating realities, challenge assumptions behind training requests, and translate business and regulatory requirements into a multi-year roadmap with clear initiatives, milestones, and measurable outcomes. Provide leadership in Global Process Ownership and Compliance (GPOC) by driving proactive quality approaches across the GxP process lifecycle, fostering a culture of continuous improvement, and ensuring that training programs are designed to enhance compliance, mitigate risks, and support operational excellence. Steward the GxP Training Quality System end-to-end within the Global QMS Governance framework. This includes establishing system standards and guardrails, interpreting global GxP expectations into defensible system-level decisions, and governing systemic risks, trends, and compliance posture. Use system-level KPIs, inspection insights, and quality performance data to assess Training Quality System health, drive continuous improvement, and escalate risks when impact exceeds defined thresholds. Represent the Training Quality System credibly and consistently during audits, regulatory inspections, and executive governance reviews. Ensure that technology architecture, configuration, and operating practices support both regulatory integrity and business effectiveness. System design must enable scalability across modalities and outsourced networks while maintaining inspection-ready evidence and disciplined governance. Lead and develop a team of Strategic Training Partners, ensuring they operate as credible, business-aligned advisors. Set clear expectations for business understanding, regulatory fluency, and solution quality, and ensure the team maintains the right mix of expertise to support evolving business needs. The Director remains accountable for overall delivery, prioritization, and performance across the portfolio. Required Capabilities The successful candidate will demonstrate the ability to operate at both strategic and system-governance levels. They must be able to define enterprise direction while stewarding a regulated Quality System with decision authority and accountability. Specifically, this role requires the ability to: Shape enterprise training strategy aligned to business priorities, regulatory expectations, and evolving operating models. In partnership with peers and leadership, drive a culture of quality and continual learning across all aspects of quality, the Quality Management System (QMS), and organizational processes. Translate regulatory requirements into defensible system-level design decisions within a formal QMS governance framework. Govern systemic quality risks and performance trends, using KPIs, inspection insights, and data to drive continuous improvement and informed escalation. Establish and enforce clear system guardrails, ensuring Process Owners and business stakeholders operate within defined standards. Balance compliance and operational practicality, applying risk-based judgment across multiple modalities and global environments. Influence senior stakeholders and governance bodies, communicating system health, risks, and decisions with clarity and credibility. Lead and mature business-aligned partner teams, setting high standards for accountability, capability, and delivery. Exercise decision authority in complex, ambiguous environments, maintaining system integrity while enabling business execution. Required Qualifications Bachelor's degree required; advanced degree preferred. 10+ years of experience in GxP training, quality systems, within regulated operational environments (or demonstrated equivalent) within pharma or biotech. This is highly preferred. 5+ years in a leadership role with accountability for strategy, governance, and people leadership. Demonstrated experience operating within a formal Quality System governance framework with deep expertise in fundamental quality disciplines and requirements (e.g., quality risk management, change management, corrective and preventing action, and inspection readiness). Strong working knowledge of FDA, EMA, and ICH GxP expectations. Proven ability to translate business and regulatory requirements into actionable strategies and defensible system-level decisions. Experience using performance data and quality metrics to inform governance and executive decision-making. Demonstrated ability to exercise sound judgment and lead through complexity. Pay Range: $175,200 - $262,800 Flex Designation: Hybrid-Eligible 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