
Demonstrated quality and lab operations leader with over 15 years of experience in regulated environments including pharmaceuticals, biotech, manufacturing, and life sciences. Proven expertise in designing and optimizing labs from the ground up, developing ISO, FDA, and cGMP compliant methods, and fostering high impact cross functional collaboration. Adept at building engaged teams, driving high performance and overall quality throughout.
Leading lab process redesigns to support faster batch turnaround and better analyst autonomy
Developing tools to streamline and improve investigation and CAPA processes
Collaborating across departments to refine raw materials workflow and integrate shared tracking system
Overseeing methodology standardization and documentation to ensure audit readiness
Continuous improvements through GMP walks and internal audits
Streamlined workflows and established metrics-based prioritization tool to support cross-functional efficiency
Acted as liaison between technical team and client services to ensure successful project execution and client satisfaction
Drove quality through deviation trend analysis, CAPA, and implementation of compliance-focused process improvements
Directed the lab buildout for new service lines, identifying infrastructure needs, procuring equipment, and ensuring regulatory compliance from concept to execution
Designed and validated testing methodologies in a cGMP environment, ensuring alignment with regulatory expectations and client requirements
Let weekly project planning with clients, direct team and support teams to maintain aligned execution and timelines
Developed progressive onboarding program that enabled team productivity and autonomy within 60 days
Partnered with business development to translate scientific needs into operational capabilities
Managed staffing, training, and inventory, maintaining high quality throughput while reducing budget by 10%
Addressed client needs and investigations directly, contributing to overall client satisfaction
Performed audits of all plant labs to ensure regulatory compliance, safety, and overall GMPs
Quality system management: SOP development, CAPA, deviation/investigation
Audit experience: internal, client quality, and regulatory
Project oversight: Budget, timeline, and resource planning
Laboratory experience: HPLC, ELISA, USP, Environmental montoring
Talent development: Team coaching, succession planning, growth planning