Senior Director, Global R&D Audits & Inspections Readiness
$207,800–$277,800 year
RemoteUnited States
Job Summary
Orchestrate global R&D audits and inspections by leading planning, execution, and wrap-up of internal, mock, and external regulatory reviews for health authorities. Embed "Validation-by-Design" principles into Agile/Scrum lifecycles and CI/CD pipelines to generate audit-ready electronic records and eliminate retrospective documentation. Translate complex global regulations including FDA 21 CFR Part 11, EMA Annex 11, and GDPR into actionable engineering guardrails and "Definition of Done" criteria. Manage the Corrective and Preventive Action (CAPA) lifecycle, conduct vendor compliance assessments, and mentor engineering teams to maintain perpetual inspection readiness. Lead a high-performing GRDTS team in a global, geographically diverse environment with some travel required.
Required Qualifications
- Bachelor's degree in Computer Science, Information Technology, Bioengineering, Lifecycle Sciences, or a related field
- 12+ years of experience in IT compliance, quality assurance, or software engineering within the pharmaceutical, biotech, or medical device industry
- 5+ years of experience directly leading or orchestrating audit/inspection readiness activities, mock audits, or live health authority inspections (FDA, EMA, MHRA, etc.)
- Proven experience working inside modern software engineering environments, explicitly embedding GxP compliance within Agile/Scrum methodologies and automated CI/CD pipelines
- Deep, authoritative understanding of global regulations and guidelines, specifically FDA 21 CFR Part 11, EMA Annex 11, and GAMP 5 principles
- Strong working knowledge of standard Computer Systems Validation (CSV) workflows paired with practical experience implementing modern Computer Software Assurance (CSA) risk-based testing practices
- Good understanding of data integrity frameworks (ALCOA+) and healthcare privacy regulations (HIPAA, GDPR) as they apply to research, tech, and clinical data repositories
- Business relationship management acumen and demonstrable success as a change agent leading or contributing to significant transformational initiatives in organizations
- Accomplished in building and development of people and teams, comfortable working with a broad cross section of people in direct and matrixed relationships
- Proficient in various project management disciplines (i.e., Agile, Scrum, Kanban, Lean)
Desired Qualifications
- An advanced degree
- Certified Quality Auditor (CQA)
- Certified Manager of Quality/Organizational Excellence (CMQ/OE)
- Certified Information Systems Auditor (CISA)
- Agile/Scrum certifications (Certified ScrumMaster, Product Owner)
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