Meet Our Founder

Leading high-stakes remediation and compliance initiatives, including:

• Designed and implemented a full sample management program for raw materials, in-process, and finished goods.
• Conducted gap analyses aligned with USP and medical device regulations.
• Served as Interim Senior QC Manager, guiding teams through critical remediation.
• Acted as SME for Environmental Monitoring, Water PQ, and CAPA reduction.

Built and led QC operations for an oncology biotech:

• Developed and implemented the company’s first Contamination Control Strategy.
• Oversaw environmental monitoring for aseptic fill-finish (Grade A/B).
• Led LIMS implementation and QC KPI reporting for Management Review.
• Supported IND/BLA submissions with microbial control documentation.

Scaled microbiology operations to support GMP manufacturing:

• Grew the team and established environmental and utility monitoring programs.
• Authored validation protocols and represented QC as SME during audits.
• Developed multi-suite microbial and viral contamination control strategies.

Global leadership in rapid microbiology innovation:

• Managed global teams across Americas, Europe, and Asia.
• Collaborated with FDA Emerging Technologies on real-time microbial detection.
• Published PDA posters on real-time water monitoring (2018–2020).
• Developed a 3-year strategic roadmap for the consulting team.

Progressive roles building foundational expertise in QC microbiology, validation, and audit readiness — supporting 510(k), BLA, and remediation projects across biotech and medical devices.

M.S. Regulatory Affairs & Health Policy (2023); Graduate Certificate in RA (2019); M.S. Operations & Project Management (2012) — connecting science, compliance and execution.