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

• 58 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:

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 Vertexs 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 persons 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