Senior Director, Global R&D Audits – Inspections Readiness

This is a fully remote position, open to applicants in United States.

📋 Description

• Ensure that both internal and external technology solutions consistently uphold regulatory compliance and are always ready for inspections.

• Design and supervise the incorporation of "Validation-by-Design" principles within Agile workflows and CI/CD pipelines.

• Coordinate health authority inspections and conduct mock audits.

• Convert global GxP and data privacy regulations into practical engineering guidelines.

• Lead the planning and execution of internal, mock, and external regulatory inspections for Research and Development (R&D).

• Oversee the Corrective and Preventive Action (CAPA) lifecycle related to R&D Systems.

• Promote a culture of innovation, accountability, and professional growth within the team.

⛳️ Requirements

• Bachelor’s degree in Computer Science, Information Technology, Bioengineering, Lifecycle Sciences, or a related discipline.

• Over 12 years of experience in IT compliance, quality assurance, or software engineering in the pharmaceutical, biotech, or medical device sectors.

• A minimum of 5 years of experience directly leading or coordinating audit and inspection readiness activities, including mock audits and live health authority inspections (FDA, EMA, MHRA, etc.).

• Demonstrated experience working within modern software engineering environments, specifically integrating GxP compliance into Agile/Scrum methodologies and automated CI/CD pipelines.

• Comprehensive and authoritative knowledge of global regulations and guidelines, particularly FDA 21 CFR Part 11, EMA Annex 11, and GAMP 5 principles.

🏝️ Benefits

• Medical

• Dental

• Vision

• 401(k)

• FSA/HSA

• Life Insurance

• Paid Time Off

• Wellness

• Employee Stock Purchase Plan

• Discretionary equity awards