Senior Director - Quality Data, Digital Systems & Compliance (Biotechnology)

Location: Boston, MA, United States. Hybrid-eligible with remote work up to two days per week, or on-site five days per week with ad hoc flexibility.

Salary: $228,000–$342,000 annual base salary, plus eligibility for an annual bonus and annual equity awards.

Company

Vertex is a global biotechnology company focused on scientific innovation and patient outcomes.

What you will do

• Advance enterprise GxP data governance frameworks, policies, standards, procedures, and data integrity practices aligned with ALCOA+ principles.
• Lead quality-related master data management, including data catalogs, business glossaries, data standards, data lineage, ownership, and stewardship.
• Define data quality standards, metrics, controls, monitoring, surveillance, and risk-based remediation for critical-to-quality data.
• Provide Quality oversight of computerized systems, including validation and assurance methodologies, lifecycle management, periodic reviews, and compliance with 21 CFR Part 11 and Annex 11.
• Drive quality analytics, business intelligence, data models, dashboards, reporting systems, and predictive models for GxP compliance and organizational decision-making.
• Lead and mentor quality professionals while partnering with Quality, IT, Regulatory, Manufacturing, Clinical, and business stakeholders on digital transformation and QMS modernization.

Requirements

• BS, MS, JD, MD, or PhD in life sciences, engineering, information systems, computer science, quality, or an equivalent discipline.
• At least 15 years of relevant experience, including 7 years in a leadership or supervisory role within a global organization.
• Experience in regulated operational or Quality environments such as GMP, GCP, or IT.
• Expertise in data integrity and governance, computer systems assurance, CSV, data quality, master data management, metadata, analytics, business intelligence, and risk management.
• Proven ability to lead digital transformation, organizational change, process modernization, stakeholder engagement, and inspection-readiness initiatives.
• Ability to work in a demanding, fast-paced, patient-focused environment with evolving processes and a start-up culture.

Nice to have

• Experience building advanced analytics, data governance strategies, and predictive quality models.
• Experience scaling quality systems across diverse products, technologies, geographies, and business needs.

Culture & Benefits

• Hybrid or on-site work design under the Flex @ Vertex program.
• Medical, dental, and vision benefits with paid time off and company shutdowns in summer and winter.
• Educational assistance, student loan repayment, commuting subsidy, charitable donation matching, and 401(k).
• Opportunities to apply AI, automation, and emerging technologies to improve decision-making and patient outcomes.