Senior DTE Audit & Compliance Leader

Vertex Pharmaceuticals Incorporated; Boston (MA); Hybrid; USD 164,000 - 247,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) and matching

Paid time off

Commuting subsidy

Job summary

Vertex Pharmaceuticals Incorporated seeks an Audit & Compliance Manager to lead IT compliance, audit coordination, and regulatory readiness across Data, Technology & Engineering and business functions.

You will partner with Internal Audit, Quality Assurance, SOX PMO, and system owners to manage audits, track findings, and drive remediation and governance metrics, while supporting health authority inspections and continuous improvement across DTE.

Qualifications

• 5-8+ years of experience in IT Compliance, Quality, Internal Audit, SOX, GxP Compliance, or a related field.
• Experience supporting audits, inspections, and remediation activities in regulated environments.
• Working knowledge of GxP, CSV/CSA, 21 CFR Part 11, SOX, NIST SP 800-53, GDPR, General IT Controls, and audit methodologies.
• Experience overseeing contractors and managed service provider work.
• Experience developing and leading remediation or risk mitigation strategies.
• Experience gathering, analyzing, and reporting compliance metrics, including dashboard content and leadership reporting.
• Strong project management skills with the ability to manage work in a complex, matrixed organization.
• Effective written and verbal communication skills with the ability to influence and align Cross-functional team members, peers, and leaders.
• Strong knowledge of application/system development methodologies and IT Service Management practices.

Responsibilities

• Serve as the primary DTE point of contact for IT-related audit, inspection, and compliance requests across GxP, Internal Audit, and operational audit activities.
• Coordinate audit and inspection preparation activities, including stakeholder readiness, request management, evidence collection, and response tracking.
• Facilitate communication between DTE teams, business stakeholders, Quality Assurance, Internal Audit, SOX PMO, and external auditors or inspectors.
• Track audit findings, observations, CAPAs, management responses, action plans, and remediation commitments through closure.
• Oversee the compliance metrics dashboard, including ongoing enhancements to monitor audit readiness, remediation progress, compliance trends, and leadership objectives.
• Promote consistent audit preparation, evidence management, documentation, and remediation practices across DTE.
• Support GxP audit and regulatory inspection readiness activities in alignment with quality and compliance expectations.
• Participate in Process Owner Network discussions regarding GxP compliance, risk, and continuous process improvement opportunities.
• Support health authority inspections and inspection readiness programs, including preparation of DTE SMEs and stakeholders.
• Coordinate IT-related internal operational audit activities for DTE.
• Support audit walkthroughs, testing activities, and auditor communications.
• Drive assigned remediation/CAPA activities to timely closure.
• Lead remediation meetings and provide clear status reporting on open actions, risks, and closure plans.
• Monitor closure commitments and elevate at-risk deadlines.
• Analyze trends in audit findings, inspection observations, remediation activities, and control performance.
• Provide audit readiness metrics, remediation updates, and compliance status reporting to leadership.
• Drive ongoing improvements to dashboard content, metrics, and reporting processes to meet leadership objectives for compliance visibility, accountability, and decision-making.
• Provide guidance on audit expectations and compliance requirements.
• Identify opportunities to improve audit processes and inspection readiness.
• Support audit management tools and governance processes.
• Contribute to training and awareness activities related to GxP, audits, and inspections.
• Promote consistency in audit preparation, evidence management, and remediation practices across DTE.
• Partner with the SOX PMO to identify process and control improvement opportunities where the SOX program intersects with overall DTE compliance efforts.

Skills

IT Compliance

Quality Assurance

SOX & GxP

Project Management

Communication

Job description

Vertex Pharmaceuticals Incorporated seeks an Audit & Compliance Manager to lead IT compliance, audit coordination, and regulatory readiness across Data, Technology & Engineering and business functions.

You will partner with Internal Audit, Quality Assurance, SOX PMO, and system owners to manage audits, track findings, and drive remediation and governance metrics, while supporting health authority inspections and continuous improvement across DTE.