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 but limited to Event, CAPA, Risk Management, Change Management, Production Controls, Materials Management, Laboratory Controls
• Proven ability to design/evolve and /or implement KPIs that are fit-for-purpose manner enabling effectiveness and assessment of the health of quality systems /QMS
• Developing individuals and teams; proven leadership capabilities within multi-level matrix organization
• Creative, innovative leadership experience complemented with strong change management experience, adaptability, resourcefulness
• Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence
• Operational Excellence experience with proven ability to lead improvement projects-Experience with Root Cause Analysis and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma
• Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions

PREFERRED EDUCATION AND EXPERIENCE:

• M.S. (or equivalent degree) and 10+ years of relevant work experience, or B.S. in a scientific or allied health field (or equivalent degree) and 12+ years of relevant work experience, or relevant comparable background
• Professional association membership and participation preferred, not required (for example: RAPS; Lean Six Sigma training/certification; SQA (GCP/GLP); ASQ; DIA)

We're enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you canchoose to work:

1.Hybridand work remotely up to two days per week;or select

2.On-Site andwork 5 days per week with ad hoc flexibility.

#LI-AR1 #LI-Hybrid

Pay Range:

Disclosure Statement:

Flex Designation:

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; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

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