Ted Gilbert
Sr Director of Compliance @OpenClinica
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WORK HISTORY
Sr Director of Compliance @OpenClinica
As Senior Director of Compliance at OpenClinica, I provide executive leadership for the company’s compliance, quality, information security, and data protection strategy, ensuring alignment with regulatory expectations while enabling business growth and customer trust.With more than 20 years of experience, I oversee enterprise programs spanning HIPAA, GDPR, ISO 27001, SOC 2, and FedRAMP, with accountability for the company’s Quality Management System, Information Security Program, and Data Protection Officer (DPO) function. I partner closely with the executive team and cross-functional leaders to assess risk, set compliance priorities, and translate regulatory requirements into scalable, operationally effective frameworks.My responsibilities include directing audit strategy and readiness, guiding investigations and CAPA, governing third-party risk, and leading organization-wide training and awareness initiatives. I focus on building sustainable systems that reduce risk, withstand regulatory scrutiny, and support long-term enterprise objectives.I am committed to positioning compliance as a strategic enabler, not a constraint; bringing clarity, consistency, and accountability to complex regulatory environments while safeguarding OpenClinica’s reputation and obligations to customers, partners, and regulators.
EDUCATION
Temple University
Certificate, Quality Assurance/ Regulatory Affairs
Delaware Valley University
BS, Biology
La Salle University
MBA, Finance
SKILLS
ABOUT TED GILBERT
I am a senior compliance and privacy leader serving as a Data Protection Officer (DPO) with deep expertise at the intersection of data protection, information security, and regulated quality systems.I lead enterprise-wide programs to ensure compliance with GDPR, HIPAA, CCPA, 21 CFR Part 11, and ICH GCP, while overseeing the design, execution, and continuous improvement of Quality Management Systems (QMS) and Information Security Programs. My work focuses on identifying risk, closing compliance gaps, and translating regulatory requirements into practical, scalable operating processes.I have a strong track record of-Driving ISO 27001 and SOC 2 certification readiness and maintenance-Leading data protection governance, including DPIAs, breach response planning, and regulatory reporting-Managing vendor and customer compliance, including DPAs, BAAs, and audit support-Strengthening organizational maturity through policy development, training, and cross-functional partnership-Streamlining CAPA, investigations, audits, and regulatory commitments to keep teams inspection-readyI am known for being a clear, credible communicator who can engage executives, technical teams, auditors, and regulators alike—bringing structure, accountability, and focus to complex compliance environments.Connect with me to discuss data protection, privacy governance, information security, or quality systems; and how disciplined compliance can become a strategic advantage rather than a constraint.
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