Senior Director, Global R&D Audits & Inspections Readiness

Responsibilities

• Partner with software engineering to integrate compliance in Agile/Scrum processes
• Oversee creation of validation deliverables during sprint cycles for proactive documentation
• Collaborate with DevOps to develop automated compliance workflows for ongoing projects
• Lead internal audits and external inspections, preparing teams for regulatory scrutiny
• Ensure external R&D IT systems consistently meet compliance standards

Qualifications

• Bachelor's in Computer Science, IT, Bioengineering, Lifecycle Sciences or related field; advanced degree preferred
• 12+ years of experience in IT compliance/QA or software engineering within pharma, biotech, or medical device sectors
• 5+ years leading audit and inspection readiness activities, including mock audits and live inspections
• Strong understanding of global regulations and healthcare data privacy requirements