Senior Director - Quality Data, Digital Systems & Compliance

Job Description

Senior Director, Quality Data, Digital Systems & Compliance
GxP Data Governance • Data Integrity • Master Data • Computer Systems Assurance • Quality Analytics

General position summary:

The Senior Director, Quality Data, Digital Systems & Compliance, serves as a pivotal leader within the Quality organization. This role provides strategic vision and direction to advance frameworks, strengthen organizational capabilities, and scale models and operations across GxP Data Integrity, Data Governance, Quality Analytics, and Digital Systems Compliance (CSA/CSV) oversight. The position promotes leading practices, supports organizational growth, and enables adaptation to evolving industry expectations as well as advanced and emerging technologies.

This role is responsible for establishing and sustaining a robust framework for GxP data integrity, master data management, computerized systems compliance (CSV/CSA), and quality analytics to ensure regulatory compliance, inspection readiness, and data-driven decision-making. Serving as a key partner to Quality, IT, Regulatory, Manufacturing, Clinical, and business stakeholders, this leader enables effective oversight, governance and stewardship of the organization's GxP quality data.

The ideal candidate will possess senior-level leadership and change management skills, extensive data integrity, governance, management and reporting expertise with demonstrated ability to implement fit-for-purpose and progressive approaches in a dynamic, innovative and scaling organization.    

Key Responsibilities:

• GxP Quality Data Governance and Data Integrity Leadership:

• Advance, scale and mature the enterprise GxP Data Governance framework, policies, standards, and procedures. 
• Provide strategic leadership and direction to GxP Data Integrity program aligned with ALCOA+ principles and global regulatory expectations.
• Chair cross-functional data governance forums and ensure clear accountability for data ownership and stewardship.

• Master Data Management (MDM) Leadership:

• Provide strategic direction and owns the model and oversight for quality-related master data across GxP functions.
• Embed the GxP MDM Model across the QMS with strategic leadership and championing data ownership, stewardship, for ensuring scalability, continuous improvement of master data quality and scalable lifecycle management processes.
• Provide strategic direction and govern data catalogs, business glossaries, data standards, and data lineage.

• Data Quality Management Leadership and Strategic Direction:

• Define GxP enterprise data quality standards, metrics, controls, and monitoring processes.
• Embed and mature proactive data quality surveillance and remediation programs.
  • Embed, scale and mature risk-based approaches for monitoring critical-to-quality data.
  • Ensure data accuracy, completeness, consistency, traceability, and fitness for intended use

• CSV/CSA & Computer Systems Quality Oversight:

• Provide strategic Quality oversight of computerized systems supporting GxP activities.
  • Ensure compliance with 21 CFR Part 11, Annex 11, and global computerized systems requirements.
• Govern validation/assurance methodologies, lifecycle management, and periodic review processes.
• Partner with DTE, quality and business leadership and stakeholders on GxP-enabling implementation, upgrades, integrations, digital capabilities, and solutions.
• Maintain inspection readiness for computerized systems and data integrity controls.

• Quality Analytics and Business Intelligence

• Partner with quality and business leadership to craft and refine the vision for quality data analytics and governance to provide real-time insight into GxP compliance, process performance and resource utilization.
• Set the strategic vision and drive development and maintenance of data models, reporting systems, data dashboards, descriptive, investigative and predictive analytics, and performance metrics to support quality delivery and organizational decision making.
• Define and drive a structured and nimble approach for ongoing and timely translation of data into

• Quality Leadership, Enterprise Partnership, Change Management and Quality Culture Championship:
  • Role models Quality Leadership, serving as a visible leader, advocating quality culture, and ensuring accountability, transparency, and integrity in how quality decisions are made and communicated across the enterprise
  • Partner with QA leadership and enabling enterprise functions (e.g., Finance, Strategic Sourcing, Human Resources) in proactive management and strategic planning and translation into operating standards, inspection readiness, compliance and excellence
  • Lead, develop, and mentor quality professionals to mature the capabilities and leadership needed to scale and transform the organization and QMS across a diverse portfolio of products, technologies, geographies, and evolving business needs.  Serve as change agent for transformation initiatives, including digitization and advanced technology integration across the QMS

Education level and/or relevant experience(s):

Required:

BS, MS, JD, MD, or PhD in a Life Sciences, Engineering, Information Systems, Computer Science, Quality discipline or equivalent.  Fifteen (15) years relevant work experience with 7 years leadership supervisory role in a global organization.

Operational/Quality experience (e.g., GMP, GCP, IT).  Experience working across business/operational functions in a regulated environment and at an enterprise level preferred.

Experience building sustainable and advanced data integrity, computer systems assurance strategies, advanced analytics, and data governance driving proactive quality management and digital/data insights enabled predictive models.

In-depth knowledge in the following areas:

Required:

• Strategic leadership across data integrity/governance and Computer Systems Assurance (CSA/CSV) programs and operations, including data quality, master data management, metadata, and governance frameworks
• Advanced analytics, business intelligence, risk management, and data-driven decision-making leadership
• Proven ability to lead digital transformation, organizational change, and process modernization initiatives. Exceptional cross-functional leadership, stakeholder engagement, and influencing skills
• Strong governance, risk management, and inspection readiness experience
• Highly collaborative and effective at building strong enterprise and cross-functional relationships; a strategic change leader who delivers results through influence, partnership, and leadership.
• Comfortable in a demanding, fast-paced, patient-focused environment with a start-up culture and evolving processes; flexible and able to adapt as business needs change.
• Hands-on, action-oriented leader willing to roll up their sleeves, with the flexibility to adapt to a start-up environment.

#LI-hybrid #LI-JS1

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range:

$228,000 - $342,000

Disclosure Statement:

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; 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. 

#LI-Hybrid
 

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