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DTE Audit & Compliance Manager (Sr. Principal Analyst)

$164.4k - $246.6k

Vertex Pharmaceuticals Inc (US)

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 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. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 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 View email address on click.appcast.io Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency. Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work. #J-18808-Ljbffr Vertex Pharmaceuticals Inc (US)

Vacancy posted 1 day ago
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