Senior Director, GxP Data Governance & Compliance (Hybrid)

Vertex Pharmaceuticals

Boston (MA)

Hybrid

USD 228,000 - 342,000

Full time

5 days ago

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Job summary

Vertex Pharmaceuticals is seeking a Senior Director of Quality Data, Digital Systems & Compliance to lead GxP data governance, data integrity, and master data across the organization. The role oversees CSA/CSV, quality analytics, and digital systems compliance, partnering with QA, IT, Regulatory, and manufacturing to ensure data-driven, inspection-ready operations.

The ideal candidate has extensive leadership experience in regulated environments, advanced analytics, and proven capability to

Qualifications

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 across regulated enterprise functions.

Responsibilities

Advance, scale and mature the enterprise GxP Data Governance framework, policies, standards, and procedures.
Provide strategic direction to GxP Data Integrity program aligned with ALCOA+ principles and regulatory expectations.
Chair cross-functional data governance forums and ensure data ownership and stewardship accountability.
Embed the MDM model across the QMS and drive data catalogs, glossaries, standards, and lineage.
Define GxP data quality standards, metrics, controls, and monitoring processes.
Maintain inspection readiness for computerized systems and data integrity controls.
Partner with Quality, IT, Regulatory, Manufacturing, Clinical, and business stakeholders on GxP systems, upgrades, integrations, and digital capabilities.