DTE Audit & Compliance Manager (Sr. Principal Analyst)

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 escalate 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.

#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.

Pay Range:

Disclosure Statement:

Flex Designation:

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.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 

#LI-Hybrid
 

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 [email protected]