Kareem Syed
Biopharma & Tech Compliance Executive | Global GxP Audit Leader | Federal Security Clearance | AI & Cybersecurity Advisor
- Role
- Director Strategic Supplier Relationship at Exelixis
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Kareem Syed
I am a biopharma and technology compliance executive with 15+ years of experience leading global GxP audits, inspection readiness, and regulatory compliance programs while driving innovation at the intersection of life sciences, cybersecurity, and AI. With an active federal security clearance, I bring a rare blend of regulated industry depth and technology-forward advisory expertise.At Exelixis, I lead enterprise-wide GVP, GCP, and GLP audit programs, ensuring inspection readiness for FDA, EMA, and MHRA. I mentor global QA teams, strengthen audit culture, and modernize compliance operations through systems such as Veeva Vault and LMS platforms.Beyond biopharma, I serve as an advisor to Ditan.ai, guiding the development of AI-powered cybersecurity audit tools, and I previously founded Ritn.ai, a health-tech venture focused on medical transcription AI. Since 2020, I have also partnered with Vianova Security, delivering FISMA audits and compliance strategies for U.S. federal agencies under clearance.I thrive at the intersection of compliance, technology, and risk management, helping organizations transform regulatory obligations into strategic advantages. Whether building inspection-ready programs, advising on cybersecurity frameworks, or leveraging AI for audit automation, I deliver executive-level leadership that drives trust, resilience, and growth.Core Strengths-Global GVP, GCP, GLP audit leadership & inspection readiness-Biopharma QA & regulatory compliance strategy-Cybersecurity & FISMA audits under federal clearance-AI & automation for compliance and risk management-Executive leadership in compliance transformation & organizational readiness
Experience
Director Strategic Supplier Relationship
Dec 2025 — Present
Accountable for strategic supplier relationship management across GCP-regulated services, with emphasis on CRO partnerships. Leading efforts to enhance supplier performance, quality oversight, and compliance while enabling scalable, efficient clinical development through strong governance and cross-functional collaboration.
Education
Santa Clara University
BS, Applied Sociology
2009 — 2012
Chicago Theological Seminary
Master's degree, Philosophy and Religious Studies
Skills
- Quality Assurance
- Public Speaking
- Cell Biology
- Biotechnology
- Protein Purification
- Strategy
- Laboratory Automation
- Microsoft Excel
- Powerpoint
- Data Analysis
- Chemistry
- Market Research
- Formulation
- Gmp
- Medical Devices
- Clinical Research
- Capa
- Gel Electrophoresis
- Monoclonal Antibodies
- Assay Development
- Elisa
- Management
- Business Development
- Tissue Culture
- Cross-Functional Team Leadership
- Sop
- Apics Trained
- Hplc
- Spectroscopy
- Molecular Biology
- Lifesciences
- Purification
- Immunoassays
- Pcr
- Microsoft Office
- Cell Culture
- In Vitro
- In Vivo
- Leadership
- Validation
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