Teams at CREO

Lead life sciences IT compliance and quality consulting projects, including CSV, CSA, risk-based validation, regulatory assessments, audits, data integrity reviews, and compliance modernization. Develop validation plans, requirements, risk assessments, test plans, trace matrices, policies, and client presentations. Evaluate regulated systems and infrastructure, support technology implementations, communicate with technical and executive stakeholders, and contribute to proposals, business development, and client relationship growth.

Leads life sciences QMS consulting engagements, including system design, implementation, remediation, audits, gap assessments, CAPA, quality documentation, regulatory compliance, and inspection readiness. Advises CROs, sponsors, and regulated organizations, manages client workstreams, presents recommendations to executives, mentors junior staff, develops proposals, and supports business development. Travel may be required based on client and project needs.