DTE Audit & Compliance Manager (Sr. Principal Analyst)

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

Benefits offered by this job

Annual bonus

Annual equity awards

Overtime pay eligibility

Job summary

Vertex Pharmaceuticals is seeking an IT Compliance leader based in Boston to serve as the primary DTE liaison for audit, inspection, and regulatory readiness across GxP, SOX, and internal controls. You will coordinate cross-functional readiness, manage evidence, and drive remediation and CAPA closure with leadership visibility.

Role requires 5-8+ years in IT Compliance, familiarity with 21 CFR Part 11, GDPR, NIST, and strong stakeholder management.

Qualifications

• 5-8+ years of IT Compliance, Quality, Internal Audit, SOX, GxP Compliance or related field.
• Experience supporting audits, inspections, and remediation in regulated environments.
• Strong knowledge of GxP, CSV/CSA, 21 CFR Part 11, SOX, NIST SP 800-53, GDPR, GCIT controls.

Responsibilities

• Serve as primary DTE contact for IT audit, inspection and compliance requests across GxP, Internal Audit and operational audits.
• Coordinate audit and inspection prep, including stakeholder readiness, evidence collection, and response tracking.
• Facilitate communication between DTE teams, QA, Internal Audit, SOX PMO and external auditors/inspectors.
• Track findings, CAPAs, management responses and closure plans.
• Oversee compliance metrics dashboard and drive enhancements for audit readiness and leadership visibility.
• Provide guidance on audit expectations, improve processes and support governance tools.

Skills

IT Compliance

Cross-functional collaboration

Communication

Education

Bachelor’s degree in IT/Compliance

Tools

GxP systems

Job description

Job Description

General 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.

GxP Audit & Regulatory Inspection Readiness

• 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.

Internal Operational Audit Coordination

• Coordinate IT-related internal operational audit activities for DTE.
• Support audit walkthroughs, testing activities, and auditor communications.

Compliance Remediation Management

• 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.

Reporting, Metrics & Governance

• 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.

Advisory & Continuous Improvement

• 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.

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.

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Pay Range: $164,400 - $246,600

Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

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