Damla Ozen /
Ozen IT Consulting
IT Consultant with 8+ years of IT Leadership experience at pre-clinical and clinical stage gene therapy biotech, and medium and large size commercial pharma. 20+ years of system lifecycle management experience with cross functional teams. Supported broad spectrum of functional areas including G&A, R&D, Regulatory Affairs, GMP and Clinical Quality, Clinical Operations, Medical Affairs, Commercial, Compliance, Portfolio and Program Management. Proven track record of building scalable and secure infrastructure and implementing systems which support biotech companies through their discovery to commercial journeys as well as IPO journeys. Hands on experience in IT compliance for Series Funding, pre&post IPO and commercial, IT Operations, GxP Computerized Systems, Privacy and Cybersecurity. Solution architect in data integration projects.
I am passionate about helping biotech companies develop right strategy to build and improve their IT capabilities. My services include:
IT Roadmap development and execution
Improvements in Information Security Posture
Privacy Program Management, GDPR Compliance
IT General Controls (ITGCs) for SOX Compliance, Audit Committee Reports
GxP Systems, CFR Part 11 Compliance, Vendor Assessments
IT Due Diligence for Series Funding and IPO Filings
IT Project Management
Technology Evaluation and Selection
Strategy definition and vendor selection to build scalable Infrastructure and systems with right resources and proper investment just for your size and budget
M&A IT Due Diligence and Integration Activities