14 дней назад
DTE Audit & Compliance Manager (Sr. Principal Analyst)
164 400 - 246 600$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
DTE Audit & Compliance Manager (Sr. Principal Analyst) (GxP, IT Compliance): Coordinating audits, regulatory inspections, remediation, and compliance reporting across Data, Technology & Engineering and business functions with an accent on GxP readiness, SOX, audit evidence, and compliance metrics. Focus on managing CAPA closure, analyzing audit and control trends, improving readiness dashboards, and aligning cross-functional stakeholders in a regulated biotechnology environment.
Location: Boston, MA, United States. Hybrid option with remote work up to two days per week, or on-site work five days per week.
Salary: $164,400–$246,600 base salary per year, plus annual bonus and equity awards.
Company
Vertex is a global biotechnology company focused on scientific innovation and delivering improved outcomes for patients.
What you will do
- Coordinate DTE audit, inspection, and compliance activities across GxP, Internal Audit, and operational audit programs.
- Manage stakeholder readiness, audit requests, evidence collection, auditor communications, and response tracking.
- Track findings, observations, CAPAs, management responses, action plans, and remediation commitments through closure.
- Support health authority inspections, GxP readiness programs, audit walkthroughs, testing, and preparation of subject-matter experts.
- Develop compliance metrics, dashboards, trend analyses, remediation updates, and leadership reporting.
- Improve audit preparation, evidence management, governance, training, and remediation practices across DTE.
Requirements
- 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 developing remediation or risk mitigation strategies, reporting compliance metrics, and managing dashboards.
- Strong project management, communication, stakeholder alignment, and cross-functional collaboration skills.
- Knowledge of application and system development methodologies and IT Service Management practices; experience overseeing contractors and managed service providers.
Culture & Benefits
- Hybrid or on-site work flexibility under the Flex @ Vertex program.
- Medical, dental, and vision benefits with paid time off and company shutdowns in summer and winter.
- Educational assistance, student loan repayment support, commuting subsidy, charitable donation matching, and 401(k).
- Continuous learning focused on AI, technology, automation, and industry trends.
- Inclusive workplace with equal employment opportunity and reasonable accommodation support.
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