Director, Global Quality Systems - Governance (Hybrid)

Job Description

The Director, Global Quality Systems, provides strategic leadership and direction in the design, oversight of execution and effectiveness of the Vertex Quality Management System (QMS) governance framework to ensure compliance with regulatory requirements, industry standards, and company policies. In collaboration with quality and business partners, the position will be responsible for operationalizing an effective QMS governance framework that drives operational excellence, risk mitigation, and continuous improvement across the organization. This position within the Quality Organization is vital to the advancement and scaling of the governance framework and oversight across the Global QMS as Vertex continues to grow and expand.  This role requires strong leadership skills, the ability to operate in a matrix organization as well as the ability to be independent and autonomous.  This role requires expert technical skills and demonstrated experience and capabilities assessing the QMS for effectiveness in execution, collaborating for change management, and championing a culture of quality and continual improvement. 

This individual will demonstrate Vertex Core Values, as well as model leadership behaviors instilling a culture of quality, engagement, development, and transparency. 

KEY RESPONSIBILITIES:

Quality Systems Governance & Compliance

• Establish and maintain a global quality management system (QMS) governance framework that ensures compliance with regulatory requirements, industry standards, and company policies
• Develop and implement GxP standards, procedures, and best practices to operationalize QMS Governance framework across GxP operations to drive operational excellence, risk mitigation, and continuous improvement

Strategic Leadership & Continuous Improvement

• Provide strategic direction for the development and enhancement of global QMS governance framework to ensure scalability and efficiency to meet emerging and future business needs across modalities (e.g., small molecule, cell, gene, device, biologics), GxP areas, and geographies.
• Drive continuous improvement initiatives, leveraging data analytics and metrics to enhance performance and compliance.
• Lead cross-functional teams to drive harmonization of governance processes, fostering a culture of quality and regulatory excellence.
• Stay abreast of evolving regulatory trends and implement proactive measures to maintain compliance.

Risk Management & Quality Oversight

• Develop and oversee risk-based approaches for quality system governance, ensuring proactive identification and mitigation of compliance risks.
• Implement key performance indicators (KPIs) to monitor the effectiveness of the quality management system and drive data-driven decision-making.
• Generation and evaluation of quality system / QMS health across modalities (e.g., small molecule, cell, gene, device, biologics), GxP areas, and geographies to understand state of compliance, areas of risks and continuous improvement opportunities

Leadership & Cross-Functional Collaboration

• Serves as a change agent fostering an enterprise mindset and culture of quality across the organization while integrating and balancing needs across modalities (e.g., small molecule, cell, gene, device, biologics), GxP areas, and geographies
• Models’ leadership, transparency, openness, respect, and partnership across interactions with staff, peers, customers, and stakeholder groups

Key Technical Knowledge, Skills and Competencies:

• Broad and deep regulatory compliance and quality operations experience (across multiple GxP areas and modalities) with leading knowledge of industry trends and best practices for efficiency, compliance, and effectiveness
• Quality oversight/governance and operational experience in CMC and one additional GxP area (e.g., GCP, GVP); experience across regions/globally and across modalities (e.g., small molecule, cell/gene therapy, medical device)
• Broad and deep quality operations experience in Quality Systems and Compliance (e,g,
• Demonstrated experience in design, management, and improvement of global quality management systems (QMS) and governance models across GxP (GLP, GCP, GVP, GMP and GDP) and modalities (medical device, small molecule, cell, gene, biologics, etc.)
• Demonstrated experience in leading/chairing Quality Governance forums (e.g. Quality Management Review)
• Regulatory inspection management experience
• Broad and deep operational and project management knowledge and experience
• Demonstrated strategic planning and execution skills required 
• Proven ability to design/evolve/measure quality systems across GxPs and product modalities including bu