DTE Audit & Compliance Manager (Sr. Principal Analyst)

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

Job Description

The Audit & Compliance Manager manages and coordinates audit, inspection, and compliance activities across Data, Technology & Engineering (DTE) and business functions. This role serves as the primary liaison between operational teams and auditors, ensuring timely preparation, execution, response, and remediation of Internal Audits, GxP audits, and regulatory inspections.

The role partners closely with Internal Audit, Quality Assurance, SOX PMO, system owners, and business teams to ensure audit commitments are met and compliance obligations are fulfilled.

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.

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.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

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.

#LI-HYBRID

#LI-Hybrid

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.

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 [e-mail]